RecruitingNot ApplicableNCT06474403

Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation

The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation


Sponsor

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Enrollment

50 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Summary

Abstract: Parastomal hernia is a frequent complication following stoma formation, presenting a significant surgical challenge with high recurrence rates. The present study explores the efficacy of the laparoscopic total extraperitoneal (TEP) approach in parastomal hernia repair, conceived as a modification of the Sugabecker's operation. This prospective work, who analysis aims to evaluate the feasibility, safety, and recurrence rates associated with this minimally invasive technique. Methods: A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed. Patient demographics, operative details, intraoperative complications, postoperative morbidity, recovery times, and hernia recurrence rates will be collate and analyze. Results: The study will include 30 patients with a median follow-up period of 1month (firstly viewer's point) and 12 months (second view point ). The all of parastomal hernias will associated with colostomies. Early mobilization will achieve, with most patients returning to their routine activities within 2 weeks. Discussion: We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods, with a favorable safety profile. The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates. Compared to the original Sugarbaker operation, where the mesh is placed intraperitoneally, the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications. Furthermore, aesthetic outcomes and patient satisfaction reports indicate a positive outlook. Conclusion: The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits, including reduced operative morbidity, faster recovery, and potentially lower recurrence rates. Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique. This study contributes to the evolving surgical management of parastomal hernias, advancing towards less invasive and more patient-centered treatment modalities.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery;
  • Symptomatic hernias requiring surgical intervention;
  • Able to undergo the surgical approach under general anesthesia;
  • Patients who can provide informed consent.
  • Patients with contraindications to laparoscopic surgery, such as uncontrolled coagulopathies, severe cardiorespiratory conditions, or extensive intra-abdominal adhesions are excluded. Those with ongoing peritonitis, incarcerated hernias requiring urgent care, or malignancy at the hernia site are also excluded.

Exclusion Criteria3

  • Patients unwilling to provide informed consent;
  • Patients with a life expectancy less than the study follow-up period;
  • Patients who have previously undergone other types of hernia repair, which could confound the operative and postoperative outcomes being measured.

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Interventions

PROCEDUREstandard Sugarbecker's operation

Eligible candidates who have developed parastomal hernias following stoma creation and consented to the study will undergo laparoscopic TEP repair. The procedure involves an initial unilateral transrectal incision followed by the creation of an preperitoneal or retro-rectus space where a mesh is positioned to reinforce the abdominal wall and the stoma. Also it will has was formed oblique hernia canal. The operative and postoperative outcomes of these patients will be studied in comparison with control group treated with the traditional Sugabecker's operation.

PROCEDUREmodified Sugarbecker's operation

Eligible candidates who have developed parastomal hernias following stoma creation and consented to the study will undergo laparoscopic TEP repair. The procedure involves an initial unilateral transrectal incision followed by the creation of an preperitoneal or retro-rectus space where a mesh is positioned to reinforce the abdominal wall and the stoma. Also it will has was formed oblique hernia canal. The operative and postoperative outcomes of these patients will be studied in comparison with control group treated with the traditional Sugabecker's operation.


Locations(1)

S.V. Ochapovsky Regional Clinical Hospital #1

Krasnodar, Russia

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NCT06474403