Is delayed surgery really better for congenital diaphragmatic hernia?: a prospective randomized clinical trial. A prospective randomized trial of delayed versus immediate repair of congenital diaphragmatic hernia. Posterior approaches in groin hernia repair with prosthesis: open or closed. A randomized comparison of suturing techniques for episiotomy and laceration repair after spontaneous vaginal birth. Controlled multicenter trial of laparoscopic transabdominal preperitoneal hernioplasty vs Shouldice herniorrhaphy. Early results. A randomized, double-blind, placebo-controlled trial to determine effectiveness of antibiotic prophylaxis for tension-free mesh herniorrhaphy. Laparoscopic or open inguinal herniorrhaphy? A randomized prospective trial. Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach. [Prospective randomized comparative study of laparoscopic hernioplasty and Lichtenstein tension-free hernioplasty].
Delayed surgery has become widely accepted in the management of congenital diaphragmatic hernia after comparing outcomes only with historical retrospective controls. It was the aim of this study to compare early and delayed hernia repair in a randomized prospective clinical trial. Fifty-four infants were randomized to receive either early repair (within 4 hours of admission) or delayed repair (more than 24 hours after birth). The survival rate was higher for the delayed group (57% v 46%), but the difference was not significant (difference: -11; 95% confidence limits: -37.5, 15.5). There were no significant differences between the two groups with respect to length of hospital stay, ventilator dependency, or survival time. Recorded preoperative risk factors were similar for the two groups. Eight infants in the delayed repair group died without having undergone surgery. The optimum time for surgery still needs clarification. From March 1990 to January 1993, a randomized prospective study was performed to determine the optimal timing of surgery for infants with high-risk congenital diaphragmatic hernia (CDH). Thirty-two CDH patients who presented with respiratory distress within 12 hours after birth were randomly divided into two groups: Group A had early repair (within 6 hours), and group B had delayed repair (at 96+ hours). Extracorporeal membrane oxygenation (ECMO) was initiated in both groups as necessary. Fourteen patients were assigned to group A, and 18 were assigned to group B. Two patients initially assigned to group A had acute deterioration, and their operations had to be postponed. Data were collected, but these patients were eliminated from the study. The two groups were comparable based on gestational age, birth weight, Bohn's criteria, and oxygenation and ventilatory index. Nine of 12 group A patients (75%) survived, and 13 of 18 group B patients (72%) survived (P > .05, not significant). The ECMO requirements for the two groups were not significantly different (8 of 12 (67%) v 16 of 18 (89%); P > .05). Surgical intervention for bleeding complications related to ECMO was required in three of eight (38%) with immediate repair and seven of 16 (44%) with delayed repair (P > .05). There was no difference in survival nor incidence of ECMO between the two groups. This is the first prospective study of timing of hernia repair that supports the conclusions of earlier reports of retrospective studies. Laparoscopic herniorraphies have been used to reduce the pain and convalescence associated with open approaches. However, there is still not any consensus of the best approach. We compared open preperitoneal and laparoscopic total extraperitoneal approaches in groin hernia repair.
                Thirty-two patients underwent open preperitoneal herniorraphy (Group I) and other 32 patients underwent total extraperitoneal repair (Group II). Time of surgery was noted. Visual Analogue Scale (VAS) was applied to evaluate the postoperative pain intensity.
                Operation time was 35 (20-65) minutes in Group I and 58 (40-85) minutes in Group II (p < 0.05). The difference of complication ratios between two groups was not significant. Laparoscopic approach was associated with less pain within postoperative 24 hours as compared to the open technique. However, after the first postoperative day, there was no longer statistically significant difference between both groups. No recurrence has yet been seen in follow-up period of 15 (4-24) months.
                Laparoscopic herniorraphy is associated with better results in term of postoperative pain within the first 24 hours as compared to open technique. To compare the continuous knotless technique of perineal repair with the interrupted method after spontaneous vaginal birth
                A randomized controlled trial.
                Canadian Task Force Classification I.
                This study was undertaken in a university hospital with more than 2200 deliveries per year. The static population of this district includes a wide range of socioeconomic classes and is predominately white.
                From May 1 to November 19, 2003, 214 primiparous women with a second-degree perineal tear or episiotomy were randomly allocated to either the continuous knotless technique (CKT; n=107) or the interrupted technique (IT; n=107) suturing method.
                The interrupted technique (IT) involves placing 3 layers of sutures whereas the continuous knotless technique (CKT) involves reapproximating vaginal trauma, perineal muscles, and skin with a loose, continuous, nonlocking technique.
                The primary outcomes of the study were perineal pain (evaluated by visual analogue scale) at 48 hours and day 10 and dyspareunia 3 months after delivery. Secondary outcomes included suture removal, wound dehiscence, analgesia use up to 48 hours, and satisfaction with repair established at 3 and 12 months after childbirth. At day 10, 19 women had dropped out of the study. Significantly fewer women reported pain at 10 days with the CKT than with the IT (32.3% vs 60.4%; p<.001). Analgesia use up to 48 hours postpartum was less in the CKT group than in the IT group (33.6% vs 54.2%; p<.05). No difference was found in superficial dyspareunia at 3 months for the CKT versus the IT group.
                The use of a continuous knotless technique for perineal repair is associated with less short-term pain than techniques with interrupted sutures. In February 1993 a prospective randomized multicenter trial was initiated to compare laparoscopic transabdominal preperitoneal hernioplasty to Shouldice herniorrhaphy as performed by surgeons of nonspecialized clinics.
                Until January 1994, 87 patients with 108 hernias took part in the trial (43 Shouldice and 44 laparoscopic repairs).
                The laparoscopic procedure took significantly longer than did the open operation but caused less pain as measured by pain analogue score and consumption of paracetamol and narcotics. The postoperative complication rate was 26% in the open and 16% in the laparoscopic group. The patients in the laparoscopic group were discharged earlier and their convalescence was shorter than after open hernia repair. There has been one early recurrence in the laparoscopic and two in the open group to date with a mean follow-up of 201 days.
                Laparoscopic hernia repair causes less pain than the conventional operation and enables the patient to return to full work and usual activities earlier. The recurrence rate will not be known for 5 years. In recent years, use of prosthetic material for inguinal hernia repair has increased dramatically. Tension-free repairs have gained popularity not only for recurrent or complicated hernias, but for primary hernia repairs as well. Although routine use of prophylactic antibiotics is not recommended in the Philippines for open nonimplant herniorrhaphy, there is little direct clinical evidence on which to base recommendations when implantable mesh is used.
                We conducted a prospective, randomized, double-blind, placebo-controlled trial comparing wound infection rates in 360 patients (180 received prophylactic antibiotics, 180 received a placebo) undergoing primary inguinal hernia repair electively using polypropylene mesh. Age, gender, American Society of Anesthesiologists class, type of hernia, type of anesthesia, and duration of operation were recorded. Infections were evaluated 1 week, 2 weeks, and 1 month after operation by an independent surgeon. All complications were recorded. Results were assessed using chi-square, Fisher's exact test, and Student's t-tests as appropriate.
                Groups were well matched for all preoperative variables studied, including comorbid conditions. Six patients from the antibiotic group and four from the placebo group failed to followup after the second week. Superficial surgical site infection developed in 3 patients (1.7%) from the antibiotic group and 6 (3.3%) from the placebo group (p = 0.50). One from each group developed deep surgical site infection. Both patients were readmitted and underwent repeated debridement, which eventually resulted in graft loss.
                Preoperative administration of single-dose antibiotic for tension-free inguinal mesh herniorrhaphy did not markedly decrease risk of wound infection in this patient population. Our results do not support use of antibiotic prophylaxis for tension-free mesh herniorrhaphy. To determine whether transabdominal preperitoneal laparoscopic hernia repair can equal or surpass an established open method at an acceptable cost.
                A randomized, prospective comparison with a follow-up of 7 to 18 months (median, 10 months; planned, 5 years).
                Health maintenance organization hospital.
                One hundred patients between 20 and 70 years of age were randomized. No patient withdrew from the study after randomization.
                Transabdominal preperitoneal laparoscopic and open tension-free repairs using a polypropylene mesh.
                Operative and discharge times, costs, recovery, and morbidity. "Return to work" was supplemented by a performance assessment using a panel of exercises.
                Operative and hospitalization times were not significantly different between the two types of repair. Patients with laparoscopic unilateral repairs returned to work faster (9 vs 17 days). At 1 week postoperatively, performance of straight-leg raises correlated well with time to return to work for patients with strenuous jobs. The laparoscopic repair was more expensive than the open approach ($3093 vs $2494).
                Laparoscopic transabdominal preperitoneal hernia repair can be accomplished with operative and hospitalization times and a short-term recurrence rate similar to those of an established open technique. Perioperative exercise testing may be an important adjunct to return to work in the comparison of methods. To compare the early and intermediate results of the open and laparoscopic tension-free repair of incisional hernia, 24 patients were randomized prospectively to undergo laparoscopic or open repair of incisional hernia with retromuscular placement of the prosthesis using transabdominal sutures for mesh fixation. All the procedures were completed as planned. The mean duration of surgery was not significantly different between the 2 groups (P=0.15). Time to oral solid food intake was longer in the open group (P=0.002). The analgesic requirement was lower in the laparoscopic group (P=0.05). One patient after open surgery and 2 in the laparoscopic group suffered postoperative complications (P=0.71). Postoperative stay was shorter in the laparoscopic group (P=0.006). No readmission or recurrence was registered within 6 months from surgery in either group. Laparoscopic incisional hernia repair, based on the Rives-Stoppa technique, is a safe, feasible alternative to open techniques. However, larger studies and long-term follow-up are required to further evaluate the true effectiveness of this operation. To compare the laparoscopic transabdominal preperitoneal inguinal hernioplasty (TAPP) and the open Lichtenstein technique, in 1992 a prospective randomized trial was initiated. Until 1995 108 patients with 130 hernias took part in the trial: 64 TAPP (group A) and 66 Lichtenstein (group B). 22 patients had simultaneous bilateral repairs. Laparoscopic approach (group A) was able to expose otherwise-occult controlateral hernias in 3 cases and discovered a complex hernia (a hernia with more than one defect in the wall) in 2 patient in whom a direct hernia had been diagnosed before the operation. Mean operating time for monolateral operations was significantly longer in group A (p < 0.05). The corresponding figures for bilateral operations were longer in group B (p < 0.01). No intraoperative complications, conversions from TAPP to open repair, postoperative deaths. There were not less pain quicker mobility and shorter period of disability in the laparoscopic group (group A). Ten (15.6%) postoperative complications occurred in group A: local hematoma (6 cases, 9.3%), neuralgias (3 cases, 4.7%), urinary retention (1 case, 1.6%). Eight (12.1%) postoperative complications: hematomas (3 cases, 4.5%), urinary retention (3 cases, 4.5%), neuralgias (2 cases, 3%) occurred in group B. Differences were not significant. The current follow-up period is 36 months (15-54) in median. In both groups no recurrences occurred, but 3 patients in group B who were operated on for monolateral hernia (6.5%) discovered to be affected by contralateral hernia. The results of the present report suggest that TAPP does not appear to be associated with better results in terms of complications, pain or period of disability as compared to open tension free hernia repair, but the ability of the laparoscopic approach to expose otherwise-occult defects eliminated the risk of recurrences due to missed hernias.
There is no clear evidence which favors delayed (when stabilized) as compared with immediate (within 24 hours of birth) timing of surgical repair of congenital diaphragmatic hernia, but a substantial advantage to either one cannot be ruled out. A large, multicenter randomized trial would be needed to answer this question.