Dataset Information

One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

ABSTRACT:

Purpose

The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair.

Methods

This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18-85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Progrip™ mesh in open inguinal hernia surgery. The primary outcome was the number of additional follow-up visits due to post-operative pain. Secondary outcomes included intensity of pain, quality of life measures, and complications.

Results

Two hundred seventy patients were included in this trial, 132 with Adhesix™ (A group), and 138 with Progrip™ (P-group). All patients' medical records were reviewed 12 months after surgery, and 207 patients (76.2%) completed 12-month follow-up. The number of patients needing additional follow-up visits 3-12 months after surgery were comparable (A group 3/3.0%, P-group 6/5.6%). The numeric rating scale was low at 12 months after surgery (at rest A 0.21, P 0.34, at exercise A 0.78, P 0.90). The incidence of chronic pain, that is moderate or severe pain during exercise, was 5 patients (5.2%) with Adhesix™ and 8 patients (7.4%) with Progrip™ (P = 0.333). Two hernia recurrences (1.0%) were established, one in each group.

Conclusion

At 1 year after hernia surgery, the use of self-gripping and self-adhesive meshes lead to successful pain reduction and quality of life improvement.

Trial registration

Clinicaltrials

com NCT03734224.

SUBMITTER: Tholix AM

PROVIDER: S-EPMC10514172 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

Thölix Anna-Maria AM Kössi Jyrki J Harju Jukka J

Langenbeck's archives of surgery 20230921 1

<h4>Purpose</h4>The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair.<h4>Methods</h4>This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18-85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Pr ...[more]

PMID: 37733083

Similar Datasets

Project description:ImportanceInguinal hernia is the most common general surgical condition in the world. Although task sharing of surgical care with nonsurgeons represents one method to increase access to essential surgery, the safety and outcomes of this strategy are not well described for hernia repair.ObjectiveTo compare outcomes after inguinal hernia repair with mesh performed by medical doctors and surgeons in Ghana.Design, setting, and participantsThis prospective cohort study was conducted from February 15, 2017, to September 17, 2018, at the Volta Regional Hospital in Ho, Ghana. Following successful completion of a training course, 3 medical doctors and 2 surgeons performed inguinal hernia repair with mesh according to the Lichtenstein technique on 242 men with primary, reducible inguinal hernia.Main outcomes and measuresThe primary end point was hernia recurrence at 1 year. The noninferiority limit was set at 5 percentage points. Secondary end points included postoperative complications at 2 weeks and patient satisfaction, pain, and self-assessed health status at 1 year.ResultsTwo-hundred forty-two patients were included; 119 men underwent operations performed by medical doctors and 123 men underwent operations performed by surgeons. Preoperative patient characteristics were similar in both groups. Two-hundred thirty-seven patients (97.9%) were seen at follow-up at 2 weeks, and 223 patients (92.1%) were seen at follow-up at 1 year. The absolute difference in recurrence rate between the medical doctor group (1 [0.9%]) and the surgeon group (3 [2.8%]) was -1.9 (1-tailed 95% CI, -4.8; P < .001), demonstrating noninferiority of the medical doctors. There were no statistically significant differences in postoperative complications (34 [29.1%] vs 29 [24.2%]), patient satisfaction (112 [98.2%] vs 108 [99.1%]), severe chronic pain (1 [0.9%] vs 4 [3.7%]), or self-assessed health (85.9 vs 83.7 of 100) for medical doctors and surgeons.Conclusions and relevanceThis study shows that medical doctors can be trained to perform elective inguinal hernia repair with mesh in men with good results and high patient satisfaction in a low-resource setting. This finding supports surgical task sharing to combat the global burden of hernia disease.

Dataset Information

One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

Purpose

Methods

Results

Conclusion

Trial registration

Clinicaltrials

Publications

One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

Similar Datasets

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