Stoma-related complications and quality-of-life assessment: A cross-sectional study with patients from Ethiopia and Sweden.

BACKGROUND: The situation for patients with ostomy can be challenging, probably more in a resource-constrained environment. Our objective was to evaluate quality of life (QoL) (using EQ5D-5L) and stoma-specific QoL (using Stoma QoL) in a high- and low-income setting. METHODS: In this cross-sectional study from the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, and South General Hospital (SGH), Stockholm, patients with a permanent or temporary ostomy at TASH (EthioPerm), (EthioTemp), and patients with ostomy at SGH (SweSto) were included in October 2022-January 2023. RESULTS: Patients N = 66 were included in groups: EthioPerm N = 28, EthioTemp N = 17, and SweSto N = 21. In EthioTemp, 88% used homemade stoma bags. Although morbidity related to the nipple itself was similar in the groups, the overall score from Stoma QoL was significantly lower in EthioPerm, 48/100 than in SweSto, 74/100. Scores were significantly lower for pouch-related problems and social interactions in Ethiopian patients. In EthioPerm, 71% of the patients worried that they were a burden to the people close to them compared to 14% in SweSto (p < 0.001). Leakage was over four times more common in EthioPerm than in SweSto. Mean overall EQ5D-5L score was 18 percentage points lower than the national mean score in EthioPerm and 2 percentage points lower in SweSto. CONCLUSION: QoL was more affected in the Ethiopian study participants than in the Swedish, even when commercial stoma bags were available. The largest problems were leakage, embarrassment with social interactions, and pouch-related problems. TRIAL REGISTRATION: NCT05970458 Clinicaltrials.gov, https://clinicaltrials.gov/study/NCT05970458?locStr=Ethiopia&country=Ethiopia&distance=50&cond=Stoma%20Ileostomy&rank=1.

PHaLIR: prevent hernia after loop ileostomy reversal-a study protocol for a randomized controlled multicenter study.

BACKGROUND: Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies. METHODS: The present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications. DISCUSSION: This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720262. Registered on October 25, 2018.

Trends in Treatment of Colorectal Cancer and Short-term Outcomes During the First Wave of the COVID-19 Pandemic in Sweden.

Importance: The COVID-19 pandemic has had a large impact on health care systems, not least the treatment of malignant diseases, including colorectal cancer. Objective: To investigate the treatment of colorectal cancer and short-term outcomes during the first wave of the COVID-19 pandemic, compared with the year before. Design, Setting, and Participants: This register-based cohort study used information from the Swedish Colorectal Cancer Registry during the years 2020 and 2019. Patients were from the Stockholm-Gotland region, 1 of 6 health care regions in Sweden, with approximately one-fifth of the country's population and 8 hospitals. All patients with a diagnosis of colorectal cancer from March 1 to August 31, 2019, and March 1 to August 31, 2020, were eligible. Data were analyzed from May to June 2021. Exposures: Diagnosis of colorectal cancer during the peak of the COVID-19 pandemic in 2020. Main Outcomes and Measures: The study aimed to compare the number of patients, time to surgery, operation methods, short-term complications, and residents' involvement in surgical practice between 2019 and 2020. Subanalyses were conducted for colon and rectal cancer. Results: A total of 1140 patients (583 men [51%]; median [IQR] age, 74 [26-99] years in 2019 and 73 [24-96] years in 2020) were enrolled. Fewer patients received a diagnosis of colorectal cancer in March through August 2020 compared with the same months in 2019 (550 vs 590 patients). Overall, patient characteristics were similar, but pretherapeutic tumor stage was more advanced in 2020 compared with 2019, with an increased proportion of T4 tumors (30% [172 patients] vs 22% [132 patients]; χ23 = 21.1; P < .001). The proportion of patients undergoing laparoscopic surgery, time to surgery, and 30-day complications were similar, but the proportion of patients treated with ostomy almost doubled between 2019 and 2020, from 17% (53 patients) to 30% (96 patients) (absolute risk, 13.0%; 95% CI, 6.8% to 20.0%). Residents participated in fewer resections in 2020 than in 2019 (35% [108 patients] vs 27% [83 patients]; absolute risk, -7.90%; 95% CI, -15.00% to -0.55%). On the other hand, the treatment and outcomes for rectal cancer were comparable between the years. Significantly more patients were transferred to the nonemergency, COVID-free hospital in the region in 2020. Conclusions and Relevance: In this Swedish register-based cohort study of patients who received a diagnosis of colorectal cancer during the most intense period of the COVID-19 pandemic, a significant increase in ostomy formation for patients with colon cancer and a lower participation of residents during surgery were observed. These changes most likely were aimed at reducing complications and intensive care unit care.

Colon cancer treatment in Sweden during the COVID-19 pandemic: A nationwide register-based study.

AIM: The COVID-19 pandemic has reduced the capacity to diagnose and treat cancer worldwide due to the prioritization of COVID-19 treatment. The aim of this study was to investigate treatment and outcomes of colon cancer in Sweden before and during the COVID-19 pandemic. METHODS: In an observational study, using the Swedish Colorectal Cancer Registry, we included (i) all Swedish patients diagnosed with colon cancer, and (ii) all patients undergoing surgery for colon cancer, in 2016-2020. Incidence of colon cancer, treatments and outcomes in 2020 were compared with 2019. RESULTS: The number of colon cancer cases in Sweden in April-May 2020 was 27% lower than the previous year, whereas no difference was observed on an annual level (4,589 vs. 4,763 patients [-4%]). Among patients with colon cancer undergoing surgery in 2020, the proportion of resections was 93 vs. 94% in 2019, with no increase in acute resections. Time from diagnosis to elective surgery decreased (29 days vs. 33 days in 2020 vs. 2019). In 2020, more patients underwent a two-stage procedure with a diverting stoma as first surgery (6.1%) vs. (4.4%) in 2019 (p = 0.0020) and more patients were treated with preoperative chemotherapy (5.1%) vs. (3,5%) 2019 (p = 0.0016). The proportion of patients that underwent laparoscopic surgery increased from 54% to 58% (p = 0.0017) There were no differences in length of stay, surgical complications, reoperation, ICU-stay or 30-day mortality between the years. CONCLUSION: Based on nationwide annual data, we did not observe adverse effects of the COVID-19 pandemic on colon cancer treatment and short time outcomes in Sweden.

Management of diastasis of the rectus abdominis muscles: recommendations for swedish national guidelines.

BACKGROUND: Diastasis of the rectus abdominis muscle is a common condition. There are no generally accepted criteria for diagnosis or treatment of diastasis of the rectus abdominis muscle, which causes uncertainty for the patient and healthcare providers alike. METHODS: The consensus document was created by a group of Swedish surgeons and based on a structured literature review and practical experience. RESULTS: The proposed criteria for diagnosis and treatment of diastasis of the rectus abdominis muscle are as follows: (1) Diastasis diagnosed at clinical examination using a caliper or ruler for measurement. Diagnostic imaging by ultrasound or other imaging modality, should be performed when concurrent umbilical or epigastric hernia or other cause of the patient's symptoms cannot be excluded. (2) Physiotherapy is the firsthand treatment for diastasis of the rectus abdominis muscle. Surgery should only be considered in diastasis of the rectus abdominis muscle patients with functional impairment, and not until the patient has undergone a standardized 6-month abdominal core training program. (3) The largest width of the diastasis should be at least 5 cm before surgical treatment is considered. In case of pronounced abdominal bulging or concomitant ventral hernia, surgery may be considered in patients with a smaller diastasis. (4) When surgery is undertaken, at least 2 years should have elapsed since last childbirth and future pregnancy should not be planned. (5) Plication of the linea alba is the firsthand surgical technique. Other techniques may be used but have not been found superior. DISCUSSION: The level of evidence behind these statements varies, but they are intended to lay down a standard strategy for treatment of diastasis of the rectus abdominis muscle and to enable uniformity of management.

Long-term Comparison of Recurrence Rates Between Different Lightweight and Heavyweight Meshes in Open Anterior Mesh Inguinal Hernia Repair: A Nationwide Population-based Register Study.

OBJECTIVE: To compare the reoperation rate for recurrence of different lightweight to heavyweight meshes after an open anterior mesh (OAM) inguinal hernia repair. SUMMARY BACKGROUND DATA: Lightweight meshes have shown benefits compared with heavyweight meshes in terms of accelerated recovery after surgery with less postoperative pain. The use of such meshes may, however, be associated with an increase in hernia recurrence. Studies of large cohorts with long-term follow-up regarding recurrence are lacking. METHODS: All OAM groin hernia repairs registered in The Swedish Hernia Register between January 1, 2005 and December 31, 2013 were eligible. Follow-up time was until June 30, 2016. Four groups of meshes were included: polypropylene (PP) heavyweight meshes >50 g/m2 (HWM), regular lightweight PP meshes <50 g/m2 (regular LWM-PP), lightweight PP mesh with absorbable poliglecaprone-25(LWM-PP/PGC), or polyglactin-910(LWM-PP/PG). Primary endpoint was reoperation for recurrence. RESULTS: 76,495 OAM inguinal hernia repairs in male patients were included for statistical analysis. 1676 repairs were reoperated for recurrence. Multivariate analysis demonstrated no significant difference of risk for recurrence between HWM and regular LWM-PP (HR 1.12, P = 0.13). LWM-PP/PGC (HR 1.42, P < 0.001) and LWM-PP/PG (HR 2.05, P < 0.001) resulted in a significant increased risk compared with HWM. Larger hernia defects, direct hernias, and recurrent hernias were associated with an increased risk of reoperation for recurrence. CONCLUSIONS: Although lightweight meshes with partially absorbable component resulted in an increased risk of recurrence, there was no difference between regular LWM-PP and HWM. Considering that regular LWM-PP has less associated side effects there are no benefits of using HWM in OAM inguinal hernia repair.

Hernia at the stoma site after loop ileostomy reversal.

PURPOSE: To estimate the incidence of and risk factors for stoma site hernia after closure of a temporary diverting ileostomy. METHOD: In a non-comparative cohort study, charts (n = 216) and CT-scans (n = 169) from patients who had undergone loop ileostomy closure following low anterior resection for rectal cancer 2010-2015 (mainly open surgery) at three hospitals were evaluated retrospectively. Patients without hernia diagnosis were evaluated cross-sectionally through a questionnaire (n = 158), and patients with symptoms of bulging or pain were contacted and offered a clinical examination or a CT scan including Valsalva maneuver. RESULTS: In the chart review, five (2.3%) patients had a diagnosis of incisional hernia at the previous stoma site after 8 months (median). In 12 patients, the CT scan showed a hernia, of which 8 had not been detected previously. The questionnaire was returned by 130 (82%) patients, of which 31% had symptoms of bulging or pain. Less than one in five of patients who reported bulging were diagnosed with hernia, but the absolute majority of the radiologically diagnosed hernias reported symptoms. By combining clinical and radiological diagnosis, the cumulative incidence of hernia was 7.4% during a median follow up time of 30 months. Risk factors for stoma site hernia were male sex and higher BMI. CONCLUSION: Hernia at the previous stoma site was underdiagnosed. Less than a third of symptomatic patients had a hernia diagnosis in routine follow up. Randomized studies are needed to evaluate if prophylactic mesh can be used to prevent hernias, especially in patients with risk factors.

Clinical and Patient-Reported Outcomes after Absorbable Strap Fixation for Ventral Hernia Repair.

INTRODUCTION: Various mesh fixation methods are employed by surgeons during ventral hernia repair. These may include tacks, straps, sutures, glue, or a combination of methods. One of these choices is an absorbable fixation device, Securestrap® (Ethicon Inc., Somerville, New Jersey), consisting of an absorbable copolymer barbed U-shaped strap with a spring-loaded deployment system. MATERIALS AND METHODS: The International Hernia Mesh Registry is a prospective multi-center registry, designed to collect longitudinal data on hernia repair methods, products, and outcomes. Patients complete the Carolinas Comfort Scale™ (CCS) (The Charlotte-Mecklenburg Hospital Authority, Charlotte, North Carolina) pre-operatively, and at one month, six months, and 12 months post-operatively. Symptomatic patients defined as responding >1 to any CCS™ question. Statistical comparison of symptom frequency was made with the McNemar test and Kaplan Meier methods to determine the recurrence rate up to 365 days. RESULTS: Patients were enrolled at 16 centers. Data was available on 100 of the 203 patients at six months and on 119 patients at 12 months. Demographics: mean age of 52.7 (13.2 standard deviation[ SD]); mean body mass index (BMI) of 33.2 (7.5 SD) kg/m2; 64.3% having a BMI over 30kg/m2; male patients 47.4%; 16.7% for recurrent hernias. Mesh fixation with straps alone in 48.3% of cases or straps and sutures in 51.7% of cases. Percentage of patients with symptomatic pain decreased slightly from baseline to one month (70.0 vs. 60.6, p=0.0782) and significantly from one month to six months (60.6% symptomatic vs. 23.2%; p=0.0004). From six months to twelve months, the change in percentage of symptomatic patients was not significant (23.2% vs. 28.7%; p=0.8084). Similar results were observed with symptomatic CCS™ movement limitations. Overall recurrence rate at 12 months was 4.72% (2.39%-9.22%). CONCLUSION: Mesh fixation with straps with or without additional sutures is associated with significant improvements in patient-reported pain and movement limitation from baseline to six months post-operative.

Quality of Life and Surgical Outcome 1 Year After Open and Laparoscopic Incisional Hernia Repair: PROLOVE: A Randomized Controlled Trial.

OBJECTIVE: Patients suffering from an incisional hernia after abdominal surgery have an impaired quality of life (QoL). Surgery aims to improve QoL with a minimum risk of further complications. The aim was to analyze QoL, predictors for outcome, including recurrence and reoperation rates during the first postoperative year. METHODS: In a randomized controlled trial comparing laparoscopic and open mesh repair, 133 patients were assessed preoperatively and after 1 year with regard to QoL using the Short Form-36 (SF-36), visual analog scale (pain, movement limitation, and fatigue), and questions addressing abdominal wall complaints. Factors concerning recurrence, reoperations, satisfaction, and improved QoL were analyzed. RESULTS: A total of 124 patients remained for analysis. All SF-36 scores except mental composite score increased, reaching and maintaining levels of the Swedish norm already after 8 weeks with no difference between groups. Event-free recovery was seen in 85% in the laparoscopic group and in 65% of the open cases (P < 0.010). Five recurrences occurred after laparoscopic surgery and 1 in the open group (P < 0.112). Overall, abdominal wall complaints decreased from 82% to 13% of the patients; and 92% were satisfied with the result after 1 year.In univariable logistic regression analyses laparoscopic surgery and male sex predicted an event-free recovery. Obesity (BMI > 30) predicted better outcome with regard to QoL. No predictors for recurrence or satisfaction were identified. CONCLUSIONS: Patients with incisional hernia benefit substantially from surgery concerning QoL, independent of surgical technique. An event-free recovery occurred frequently after laparoscopic surgery. SF-36 seems well suited for assessing surgical outcome in patients after incisional hernia repair.

Feasibility of a combined percutaneous laparoscopic three-millimeter device.

BACKGROUND AND OBJECTIVES: Needlescopic 3-mm instruments induce minimal trauma and produce excellent cosmetic results. A combination of a 3-mm abdominal wall incision and a 5-mm instrument in the abdominal cavity would combine the beneficial features of these two different sizes. METHODS: The Percutaneous Surgical System (PSS) (Ethicon EndoSurgery, Galway, Ireland) is a new instrument consisting of a 3-mm shaft that is introduced percutaneously into the abdominal cavity. Through a 5-mm trocar, a loader with a 5-mm attachment such as a Maryland dissector is introduced. The attachment is connected to the shaft, and the loader is removed from the abdomen. The feasibility of this device was evaluated retrospectively in 3 Swedish hospitals between January and September 2012. RESULTS: Twenty-eight patients were laparoscopically operated on (cholecystectomy, gastric bypass, fundoplication, incisional hernias, and totally extraperitoneal repair for inguinal hernia) by use of 1 or 2 PSSs in each operation (47 in total). It was feasible to use the PSS in all procedures except during the totally extraperitoneal repair procedure because of the limited available preperitoneal space. Especially in laparoscopic cholecystectomies, the two lateral 5-mm trocars were easily replaced by two 3-mm PSS instruments. CONCLUSIONS: The use of the PSS is feasible in a number of laparoscopic procedures, where it can replace 5-mm trocars. Randomized controlled trials are needed to determine the future role of the PSS versus, for example, needlescopic laparoscopy.

Omentectomy in addition to gastric bypass surgery and influence on insulin sensitivity: a randomized double blind controlled trial.

BACKGROUND & AIMS: Accumulation of visceral adipose tissue is associated with insulin resistance and cardio-vascular disease. The aim of this study was to elucidate whether removal of a large amount of visceral fat by omentectomy in conjunction with Roux en-Y gastric bypass operation (RYGB) results in enhanced improvement of insulin sensitivity compared to gastric bypass surgery alone. METHODS: Eighty-one obese women scheduled for RYGB were included in the study. They were randomized to RYGB or RYGB in conjunction with omentectomy. Insulin sensitivity was measured by hyperinsulinemic euglycemic clamp before operation and sixty-two women were also reexamined 2 years post-operatively. The primary outcome measure was insulin sensitivity and secondary outcome measures included cardio-metabolic risk factors. RESULTS: Two-year weight loss was profound but unaffected by omentectomy. Before intervention, there were no clinical or metabolic differences between the two groups. The difference in primary outcome measure, insulin sensitivity, was not significant between the non-omentectomy (6.7 ± 1.6 mg/kg body weight/minute) and omentectomy groups (6.6 ± 1.5 mg/kg body weight/minute) after 2 years. Nor did any of the cardio-metabolic risk factors that were secondary outcome measures differ significantly. CONCLUSION: Addition of omentectomy to gastric bypass operation does not give an incremental effect on long term insulin sensitivity or cardio-metabolic risk factors. The clinical usefulness of omentectomy in addition to gastric bypass operation is highly questionable. CLINICAL TRIAL REGISTRATION NUMBER: NCT01785134.

Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial.

OBJECTIVE: : The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain, quality of life (QoL), recovery, and complications. BACKGROUND: : Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons. METHODS: : Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were randomized to either laparoscopic (LR) or open sublay (OR) mesh repair. Primary end point was pain at 3 weeks, measured as the bodily pain subscale of Short Form-36 (SF-36). Secondary end points were complications registered by type and severity (the Clavien-Dindo classification), movement restrictions, fatigue, time to full recovery, and QoL up to 8 weeks. RESULTS: : Patients were recruited between October 2005 and November 2009. Of 157 randomized patients, 133 received intervention: 64 LR and 69 OR. Measurements of pain did not differ, nor did movement restriction and postoperative fatigue. SF-36 subscales favored the LR group: physical function (P < 0.001), role physical (P < 0.012), mental health (P < 0.022), and physical composite score (P < 0.009). Surgical site infections were 17 in the OR group compared with 1 in the LR group (P < 0.001). The severity of complications did not differ between the groups (P < 0.213). CONCLUSIONS: : Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR, but the LR results in better physical function and less surgical site infections than the OR does. (ClinicalTrials.gov Identifier: NCT00472537).

Studies on the mechanism of accumulation of cholesterol in the gallbladder mucosa. Evidence that sterol 27-hydroxylase is not a pathogenetic factor.

BACKGROUND/AIMS: Cholesterolosis is characterized by accumulation of esterified cholesterol in human gallbladder mucosa. The present study aimed at investigating possible pathogenetic factors for cholesterolosis. The hypothesis was tested that a reduced sterol 27-hydroxylase or an increased amount of ACAT-1 enzyme may be of importance. METHODS: Gall bladder mucosa and bile were obtained from patients with cholesterol gallstones undergoing cholecystectomy (30 with and 43 without cholesterolosis). RESULTS: In cholesterolosis, the gall bladder mucosa was characterized by a several-fold increase in esterified cholesterol and normal content of free cholesterol. The amount of ACAT-1 protein, measured by immunoblotting, was similar in patients with and without cholesterolosis. The level of 27-hydroxycholesterol in gallbladder mucosa was elevated sevenfold as compared with cholesterol in patients with cholesterolosis. Most (87%) of this oxysterol was esterified and the accumulation is most probably secondary to the higher total amount of cholesterol in the cells. Patients with cholesterolosis had normal levels of both sterol 27-hydroxylase mRNA (real time polymerase chain reaction) and protein (immunoblotting). The enzymatic activity of the sterol 27-hydroxylase in gallbladder mucosa was normal or increased in cholesterolosis. CONCLUSIONS: The pathogenesis of cholesterolosis may be multifactorial, but is not caused by reduced efflux of cholesterol due to a defect sterol 27-hydroxylase mechanism.

Early results of a single-blinded, randomized, controlled, Internet-based multicenter trial comparing Prolene and Vypro II mesh in Lichtenstein hernioplasty.

BACKGROUND: The standard polypropylene mesh used in Lichtenstein's operation induces a strong foreign-tissue reaction with potentially harmful effects. A mesh with less polypropylene could possibly be beneficial. PATIENTS AND METHODS: Six hundred men with inguinal hernias were randomized to Lichtenstein's operation with Prolene or Vypro II in a single-blinded multicenter trial. The randomization was performed by a computer algorithm in a database through the Internet. All data were entered and directly validated in the database through the Internet. RESULTS: The meshes had comparable results in return to work, return to daily activities, complications, postoperative pain, and quality of life during the first 8 weeks of rehabilitation. CONCLUSIONS: Lichtenstein's operation with either Prolene or Vypro II is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery. The study was facilitated by the use of a database through the Internet.

[The Internet a good web for gathering data for clinical trials and registries. Traditional paper data forms are soon completely "out"]. / "Webben" ett bra nät för insamling av studie- och registerdata. Pappersbaserade lösningar snart helt "ute".

With the development of the Internet technology, clinicians have got a valuable tool for solving some of the logistic problems affecting multicenter studies and registers. Web based solutions enhance efficiency and quality of multicenter studies. Data can be entered continuously without any time and geographical limitations. On-line connection to a central database improves involvement of participants, and information and alterations can easily be disseminated. The central database enables optimal randomization and stratification. Furthermore, web based IT solutions for studies and registers enable the patients to report their data directly into the database. Until now web based IT solutions have been rather expensive but may gradually come down in price.

Tension-free inguinal hernia repair: TEP versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial.

OBJECTIVE: To compare laparoscopic hernioplasty with two open tension-free hernia repairs. SUMMARY BACKGROUND DATA: Laparoscopic hernioplasty is associated with a short rehabilitation, but it is a technically difficult procedure. It is unclear if it has advantages over the technically easier open tension-free herniorrhaphy. METHODS: Two hundred ninety-nine men 30 to 75 years old were randomized to undergo laparoscopic totally extraperitoneal hernioplasty (TEP), open operation with mesh-plug and patch, or Lichtenstein's operation. RESULTS: Two hundred ninety-four (98%) patients were followed for 19.8 +/- 8.6 months. Over 90% of the patients in all groups were operated in day surgery; the rest of the patients were all discharged within 24 hours. Postoperative pain (visual analog score) was lower in the patients undergoing TEP than in those undergoing Lichtenstein and mesh-plug procedures. The median sick-leave period was 5 days in the TEP group, 7 days in the mesh-plug group, and 7 days in the Lichtenstein group. The median time to full recovery was significantly shorter in the TEP group compared to the other two groups. There were no major complications. Two recurrences were found in the TEP group and two in the mesh-plug group. CONCLUSIONS: Laparoscopic hernioplasty is superior to tension-free open herniorrhaphy in terms of postoperative pain and rehabilitation.