Mesh Versus Patch Repair for Epigastric and Umbilical Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled Trial

Design

This trial is a randomized controlled, patient-blinded, multicentre, superiority trial.

Methods

All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED^® Ventral Patch) (PVP). The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complication rates.

Results

A total of 352 patients were randomized in this trial; 348 patients received the intervention (n = 177 PVP vs. n = 171 mesh). No peri-operative complications occurred. PVP placement was significantly faster compared to mesh placement (30 min, SD 11 vs. 35 min, SD 11) and was scored as an easier procedure. At 1-month follow-up, 76 patients suffered any kind of complication. There was no significant difference in the proportion of complications (24.9% for PVP and 18.7% for mesh, p = 0.195). A significant difference was seen in re-operation rate within 1 month, significantly less early re-operations in the mesh group (0.0 vs. 2.8%, p = 0.027). After 1-year follow-up, no significant differences are seen in recurrence rates (n = 13, 7.8% PVP vs. n = 5, 3.3% mesh, p = 0.08).

Conclusions

Both mesh and PVP had a comparable amount of reported complications. There was a significantly higher incidence of early re-operations due to early complications in the PVP group. No differences were seen in infection rates and the need for antibiotic treatment. No significant difference was seen in the recurrence rates.

Registration

This trial was registered in the Dutch Trail Registry (NTR) NTR2514NL33995.060.10. [12].

     

Stapled and Open Hemorrhoidectomy: Randomized Controlled Trial of Early Results

Abstract The aim of the study was to compare the early results in 52 patients randomly allocated to undergo either stapled or open hemorrhoidectomy. Seventy-four patients with grade III and IV hemorrhoids were randomly allocated to undergo either stapled (37 patients) or open (37 patients) hemorrhoidectomy. Stapled hemorrhoidectomy was performed with the use of a circular stapling device. Open hemorrhoidectomy was accomplished according to the Milligan-Morgan technique. Postoperative pain was assessed by means of a visual analogue scale (V.A.S.). Recovery evaluation included return to pain-free defecation and normal activities. A 6-month clinical follow-up and a 17.5 (10 to 27)-month median telephone follow-up was obtained in all patients. Operation time for stapled hemorrhoidectomy was shorter (median 25 [range 15 to 49] minutes versus 30 [range 20 to 44] minutes, p = 0.041). Median (range) V.A.S. scores in the stapled group were significantly lower (V.A.S. score after 4 hours: 4 [2 to 6] versus 5 [2 to 8], p = 0.001; V.A.S. score after 24 hours: 3 [1 to 6] versus 5 [3 to 7], p = 0.000; V.A.S. score after first defecation: 5 [3 to 8] versus 7 [3 to 9], p = 0.000). Resumption of pain-free defecation was significantly faster in the stapled group (10 [6 to 14] days vs 12 [9 to 19] days, p = 0.001). At follow-up 4 weeks and 6 months postoperatively the median (range) symptom severity score was similar in both groups (1 [0 to 2] versus 0 [0 to 3], p = 0.150 and 0 [0 to 2] versus 0 [0 to 2], p = 0.731). At long-term follow-up occasional pain was present in 6/37 (16.2) patients in the stapled group and 7/37 (18.9%) in the Milligan-Morgan group (p = 1.000); episodes of bleeding were reported by 8/37 (21.6%) patients in the stapled group and 5/37 (13.5%) patients in the Milligan-Morgan group (p = 0.542). No problems related to continence and defecation were reported in either group. Patients were satisfied with the operation in 33/37 (89.2%) cases in the stapled group and 31/37 (83.8%) cases in the Milligan-Morgan group (p = 0.735). Hemorrhoidectomy with a circular staple device is easy to perform and achieves better results than the Milligan-Morgan technique in terms of postoperative pain and recovery. Comparable results are obtained at long-term follow-up.     

Minimization of Immunosuppressive Therapy After Renal Transplantation: Results of a Randomized Controlled Trial

Modern immunosuppressive regimens reduce the acute rejection rate by combining a cornerstone immunosuppressant like tacrolimus or cyclosporine with adjunctive agents like corticosteroids, mycophenolate mofetil (MMF) or azathioprine, often associated with untoward side effects. A 6-month randomized study was conducted in 47 European centers. Triple therapy with tacrolimus (trough levels 5-15 ng/mL), corticosteroids (dosage 10 mg/day) and MMF (1 g/day) was administered for 3 months. From day 92, patients either continued with triple therapy (control, n = 277), or stopped steroids (n = 279), or stopped MMF (n = 277). Surrogate markers for long-term benefits were changes in lipid profiles and occurrence of hematological, gastrointestinal and infectious complications. The 6-month acute rejection incidence (biopsy-proven) was similar in all groups (17.0% vs. 15.1% vs. 14.8%, p = 0.744), although the incidence after month 3 was higher in the steroid stop group than in the two other groups. Mean reductions in total cholesterol (18.9 mg/dL [0.49 mmol/L]) and LDL-cholesterol (8.1 mg/dL [0.21 mmol/L]) between months 4 and 6 were greater in the steroid stop group (p < 0.001). Leukopenia (p = 0.0082), serious CMV infection (p = 0.024), anemia (p = NS) and diarrhea (p = NS) were less frequent in the MMF stop group. In a study population of immunologically low-risk patients' withdrawal of corticosteroids or MMF from a tacrolimus-based therapy at 3 months was feasible. A longer follow-up will be needed to confirm the expected advantages for the long-term outcome and to assess the long-term safety of this minimization of immunosuppressive therapy.     

Radiofrequency Microdebridement Versus Surgical Decompression for Achilles Tendinosis: A Randomized Controlled Trial

Achilles tendinosis is primarily managed nonoperatively with activity modification and physiotherapy, although surgery can be required. This has classically involved surgical decompression of the Achilles tendon, although the use of radiofrequency microdebridement has been suggested as a novel minimally invasive alternative. We present a randomized controlled trial comparing radiofrequency microdebridement using the Topaz^® microdebrider wand and traditional surgical decompression. All patients with Achilles tendinosis referred to a single surgeon and meeting the inclusion criteria were invited to participate in our single-blinded, randomized controlled study. The Victorian Institute of Sports Assessment–Achilles (VISA-A) questionnaire and the visual analog scale were used as measures at baseline and 6 months postoperatively. From 2009 to 2014, 16 patients were randomized to traditional decompression treatment and 20 to Topaz^® treatment. All surgical procedures were performed as day-case procedures with the patient under general anesthetic by a single surgeon. No significant differences were found between the groups in demographic data. At 6 months after intervention, both groups demonstrated an improvement in the Victorian Institute of Sports Assessment–Achilles and visual analog scale scores compared with baseline, with no difference found between treatment modalities at 6 months. The Topaz^® microdebrider resulted in variable outcomes after surgery and is not without complications. Regarding the patient-reported outcome measures, Topaz^® conferred no additional benefit compared with traditional surgical decompression and we have stopped using Topaz^® in our treatment of Achilles tendinosis.     

Open Versus Laparoscopic Vertical Banded Gastroplasty: A Randomized Controlled Double Blind Trial

Background:Vertical banded gastroplasty (VBG) is a frequently used surgical procedure for the treatment of morbid obesity. It can be done open (OVBG) or laparoscopic (LVBG). The aim of this double-blind randomized clinical trial was to compare the postoperative outcome and 1-year follow-up of 2 cohorts of patients who underwent either OVBG or LVBG. Patients and Methods: 30 patients with morbid obesity were randomized into 2 groups (14 OVBG and 16 LVBG). Pain intensity, analgesic requirements, respiratory function, and physical activity were blindly analyzed during the first 3 postoperative days. Complications, weight loss, and cosmetic results after 1 year follow-up were evaluated. Results: Both groups were highly comparable before surgery. Surgical time was longer in the laparoscopic procedure. Patients in this group required less analgesics during the first postoperative day.There was an earlier recovery in the expiratory and inspiratory forces, as well as faster recovery of physical activities in patients who underwent LVBG. Postoperative complications were more frequent in the open group. Excess body weight loss after 1 year was similar in both groups. Cosmetic results were significantly better in the laparoscopic group. Conclusions: LVBG had advantages over the open procedure in terms of analgesic requirements, respi function, postoperative recovery, and cosmetic results.     

Randomized Controlled Single-Center Trial Comparing Pancreatogastrostomy Versus Pancreaticojejunostomy After Partial Pancreatoduodenectomy

Background

The aim of this single-center randomized trial was to compare the perioperative outcome of pancreatoduodenectomy with pancreatogastrostomy (PG) vs pancreaticojejunostomy (PJ).

Methods

Randomization was done intraoperatively. PG was performed via anterior and posterior gastrotomy with pursestring and inverting seromuscular suture; control intervention was PJ with duct?Cmucosa anastomosis. The primary endpoint was postoperative pancreatic fistula (POPF).

Results

From 2006 to 2011, n?=?268 patients were screened and n?=?116 were randomized to n?=?59 PG and n?=?57 PJ. There was no statistically significant difference regarding the primary endpoint (PG vs PJ, 10?% vs 12?%, p?=?0.775). The subgroup of high-risk patients with a soft pancreas had a non-significantly lower pancreatic fistula rate with PG (PG vs PJ, 14 vs 24?%, p?=?0.352). Analysis of secondary endpoints demonstrated a shorter operation time (404 vs 443?min, p?=?0.005) and reduced hospital stay for PG (15 vs 17?days, p?=?0.155). Delayed gastric emptying (DGE; PG vs PJ, 27 vs 17?%, p?=?0.246) and intraluminal bleeding (PG vs PJ, 7 vs 2?%, p?=?0.364) were more frequent with PG. Mortality was low in both groups (<2?%).

Conclusions

Our randomized controlled trial shows no difference between PG and PJ as reconstruction techniques after partial pancreatoduodenectomy. POPF rate, DGE, and bleeding were not statistically different. Operation time was significantly shorter in the PG group.     

Oncologic Results of Laparoscopic Versus Conventional Open Surgery for Stage II or III Left-Sided Colon Cancers: A Randomized Controlled Trial

Introduction Minimal invasive surgical approach can achieve quick functional recovery. However, the oncologic outcome for cancer is still a concern. This study aims to compare the oncologic outcome between laparoscopic and open methods in the curative resection of Stage II or III left-sided colon cancers. Methods In consideration of statistical power up to 90%, 286 eligible patients with curable left-sided colon cancer (Tumor-Node-Metastasis Stage II and Stage III disease) requiring the takedown of colonic splenic flexure to facilitate a curative left hemicolectomy were recruited randomly and equally allocated to the laparoscopic and open group. The primary endpoint was time-to-recurrence of tumor. Data was analyzed according to intention-to-treat principle. Results Postrandomization exclusion occurred because of metastatic disease detected intraoperatively occurred in 13 patients and because of patient withdrawal from trial in 4. Therefore, 135 and 134 patients actually comprised the laparoscopic and open group, respectively. The median follow-up of patient was 40 months (range: 18–72 months). The oncologic results were similar (P = 0.362, one-sided log-rank test) in laparoscopic and open group of patients, with the estimated cumulative recurrence rate of 13.2% (9/68) versus 17.2% (11/64) in Stage II disease and 20.9% (14/67) versus 25.7% (18/70) in Stage III disease, respectively. The recurrence patterns were similar between the two groups. Both open and laparoscopic groups were comparable in the number of dissected lymph node (15.6 ± 3.0 vs. 16.0 ± 6.0, P = 0.489), various demographic and clinicopathologic parameters. Conclusions The estimated cumulative recurrence rate for the surgery of Stage II or III left-sided colon cancers was the same between laparoscopic and open methods.     

Tension-free Laparoscopic and Open Hernia Repair: Randomized Controlled Trial of Early Results

The aim of the study was prospectively to compare the early results and outcome in 105 patients randomly allocated to undergo tension-free laparoscopic hernia repair (LHR) with transabdominal preperitoneal technique (53 patients) or open hernia repair (OHR) with mesh apposition (52 patients). The mean (SD) operation time was longer in the LHR group than in the OHR group: 49.6 (5.4) versus 33.9 (6.2) minutes; p < 0.001. One laparoscopic case was converted to open repair to deal with a hemorrhage from an aberrant obturatory artery at the level of Cooper's ligament. Groin discomfort or pain was the most common complication after both procedures. The patients requiring none, one, two, or more than two doses of intramuscular diclofenac were, respectively, 40.4%, 40.4%, 15.4%, and 3.8% after LHR and 50.0%, 30.8%, 17.3%, and 1.9% after OHR (p= 0.69; NS). The mean ± SEM (range) postoperative visual analog scale score, ranging from 0 (no pain) to 10 (worst pain imaginable), was 3.1 ± 0.2 (1–7) in the LHR subset and 2.7 ± 0.2 (1–5) in the OHR group (p= 0.14; NS); on the second postoperative day the score was 2.3 ± 0.2 (1–6) and 1.8 ± 0.1 (1–4), respectively (p < 0.03). The time ± SEM (range) of resumption of pain-free normal activities and work was faster in OHR group: 6.1 ± 0.2 (4–8) weeks versus 6.5 ± 0.1 (4–8) weeks; p < 0.03. Our results showed that tension-free open hernia repair is superior to LHR in terms of postoperative pain with no important differences in recovery.     

Harmonic Scalpel Versus Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial

Purpose

To test the hypothesis that the use of a harmonic scalpel increases operative time but results in less estimated blood loss, postoperative pain, drainage volume, and duration of surgery, as well as fewer complications, such as flap necrosis, seroma, and surgical site infection (SSI), than electrocautery.

Methods

This parallel-group, single-institution blinded randomized controlled trial was conducted at the department of surgery of our institute between April 2010 and July 2011. Women undergoing modified radical mastectomy were randomly allocated to either harmonic dissection (n = 76) or electrocautery (n = 76).

Results

Both the groups were comparable for baseline variables with age of 50.5 ± 12.2 and 48.5 ± 14.5 years in the harmonic and electrocautery groups, respectively. Harmonic dissection yielded better outcomes compared to electrocautery with lower estimated blood loss (100 ± 62 vs. 182 ± 92, p < 0.001), less drain volume (631 ± 275 ml vs. 1035 ± 413 ml, p < 0.001), fewer drain days (12 ± 3 vs. 17 ± 4, p < 0.001), less seroma formation (21.3 vs. 33.3 %, p = 0.071), and less postoperative pain [median (interquartile range) 2 (2–2) vs. 3 (3–4), p < 0.001], whereas mean operative time (191 ± 44 vs. 187 ± 36 min, p = 0.49) and SSI (0 vs. 4 %, p = 0.122) did not differ. On multivariable Cox regression analysis, harmonic dissection was associated with lower risk of significant postoperative pain [adjusted relative risk 0.028 (95 % confidence interval (CI) 0.004–0.2)] and overall complications [adjusted relative risk 0.47, (95 % CI 0.26–0.86)]. On multiple linear regression, duration of drains in the harmonic dissection group was 4.5 days less than electrocautery (r ² = 0.28, β = 11.8, p < 0.001).

Conclusions

The harmonic scalpel significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time. We thus recommend preferential use of harmonic dissection in modified radical mastectomy. (ClinicalTrials.gov NCT01587248).     

Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial

Background

The incisional surgical site infection (SSI) is an extremely common complication following open abdominal surgery and imposes a considerable treatment and cost burden.

Method

We conducted a multicenter open-label randomized controlled trial at three Tokyo Metropolitan medical institutions. We enrolled adult patients who underwent either an elective or an emergency open laparotomy. Eligible patients were allocated preoperatively to undergo wound closure with either subcuticular sutures or staples. A central Web-based randomization tool was used to assign participants randomly by a permuted block sequence with a 1:1 allocation ratio and a block size of 4 before mass closure to each group. The primary endpoint was the occurrence of a superficial SSI within 30 days after surgery in accordance with the Centers for Disease Control and Prevention criteria. This trial was registered with UMIN-CTR as UMIN 000004836 (http://www.umin.ac.jp/ctr).

Results

Between September 1, 2010 and August 31, 2015, 401 patients were enrolled and randomly assigned to either group. One hundred and ninety-nine patients were allocated to the subcuticular suture and 202 patients to the staple groups (hereafter the “suture” and “staple” group, respectively). Three hundred and ninety-nine were eligible for the primary endpoint. Superficial SSIs occurred in 25 of 198 suture patients and in 27 of 201 staple patients. Overall, the rate of superficial SSIs did not differ significantly between the suture and staple groups.

Conclusion

Subcuticular sutures did not increase the occurrence of superficial SSIs following open laparotomies mainly consisting of clean-contaminated surgical procedures. The applicability of the wound closure material and method is likely to depend on individual circumstances of the patient and surgical procedure.

     

The Phlebectomy Probe: A New and Useful Instrument for Ambulatory Phlebectomy

BACKGROUND: Tethering of varicose veins by periadventitial connective tissue can limit the length of vein segment that can be avulsed during ambulatory phlebectomy. A thin, malleable blunt probe is described which can dissect connective tissue adhesions surrounding varicose veins. This probe can be used as an endoluminal probe to localize elusive veins. OBJECTIVE: We describe the use of a new type of phlebectomy probe for periadventitial dissection and endoluminal probing during ambulatory phlebectomy. METHODS: The techniques of periadventitial dissection and endoluminal probing are reviewed. RESULTS: The phlebectomy probe seems to permit extraction of longer segments of varicose veins after releasing periadventitial adhesions. Endoluminal probing can assist in difficult localization of venous segments. CONCLUSION: The phlebectomy probe can be helpful for releasing periadventitial adhesions that tether varicose veins. Its application is simple and can result in increased length of avulsed varicose vein segments, thereby reducing the number of incisions needed.     

Prospective Randomized Blind Controlled Trial Comparing Sutures, Tape, and Octylcyanoacrylate Tissue Adhesive for Skin Closure After Phlebectomy

BACKGROUND: The patient's view of the outcome after phlebectomy is mainly dependent on the cosmetic result. OBJECTIVE: To compare 5-0 monofilament sutures with tapes and tissue adhesive for wound closure after varicose vein surgery. METHODS: Seventy-nine patients undergoing varicose vein surgery were prospectively randomized in three groups (tissue adhesive, sutures, tape) for skin closure and compared. The follow-up 1 year postoperatively was done by a senior dermatologist who was blinded in the method of skin closure. RESULTS: The cosmetic outcome showed little advantage for the suture group. Taping the incisions is faster than suturing them but without significance; closure with tissue adhesive takes nearly the double of time. The closure for one incision with tissue adhesive is 40 times more expensive than with tapes and 14 times more expensive than with sutures. CONCLUSION: This study failed to demonstrate an advantage of tissue adhesive and tapes over monofilament sutures for skin closure after phlebectomy.     

Desarda Versus Lichtenstein Technique for Primary Inguinal Hernia Treatment: 3-Year Results of a Randomized Clinical Trial

Background  

The Shouldice method and other tissue-based techniques are still acknowledged to be acceptable for primary inguinal hernia repair according to the European Hernia Society guidelines. Desarda’s technique, presented in 2001, is an original hernia repair method using an undetached strip of external oblique aponeurosis. This randomized trial compared outcomes after hernia repair with Desarda (D) and mesh-based Lichtenstein (L) techniques.