Parastomal HerniaLTEPPNCT06474403
Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
A study testing standard Sugarbecker's operation and modified Sugarbecker's operation in people with Parastomal Hernia, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- standard Sugarbecker's operation and modified Sugarbecker's operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jan 2024to 12 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Non-Inclusion Criteria:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
S.V. Ochapovsky Regional Clinical Hospital #1
Krasnodar, 350040
About this study
Official title: The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
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.
Read more
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.
Read the detailed description
Introduction:
Parastomal herniation presents as a common complication following stomal surgeries, creating significant morbidity and adversely impacting the quality of life for patients. Traditional open surgical techniques, including Sugabecker's operation, offer variable success rates and potential complications. This study proposes an adaptation utilizing a laparoscopic total extraperitoneal (TEP) approach, tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs.
Objective:
The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabecker's operation and to assess its outcomes in terms of feasibility, safety, and hernia recurrence rate.
Brief Protocol Description:
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.
Scientific Hypothesis:
The hypothesis underpinning this research is that a laparoscopic TEP approach to parastomal hernia repair, modifying Sugabecker's procedure, can provide more favorable outcomes, for example: less intraoperative trauma, fewer bowel injuries due to adhesiolysis, and fewer intestinal perforations. Specifically, it is expected that this minimally invasive method will result in a significant reduction in postoperative pain, shorter hospital stays, faster recovery, decreased morbidity, and lower hernia recurrence rates in comparison with the traditional Sugabecker's or Paul's operations.
Expected Results:
This study anticipates that the laparoscopic TEP repair will demonstrate:
- A safe and reproducible procedure adaptable to different hernia sizes and locations around stomas.
- Reduced immediate intra - and postoperative complications, including infections and hematoma formation.
- Quicker patient mobilization and discharge times when compared with the open approach.
- A statistically significant reduction in parastomal hernia recurrence over a long-term follow-up when matched against controls who have undergone traditional Sugabecker's repair.
- High patient satisfaction scores and improved quality of life indicators due to the minimally invasive nature of the repair.
In conclusion, through a detailed analysis of perioperative outcomes, long-term follow-up, and comparative studies with traditional methods, this research aims to establish the laparoscopic TEP approach as a superior modification to parastomal hernia repair, upholding the tenets of enhanced recovery and patient-centered care.
- Conditions
- Parastomal Hernia
- Being tested
- standard Sugarbecker's operation, modified Sugarbecker's operation
- Keywords
- Parastomal Hernia, Hernia Recurrence, Minimally Invasive Surgery, Sugabecker's Operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard Sugarbecker's operationProcedure or surgery
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.
modified Sugarbecker's operationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| standard Sugarbecker's operation | Other | patients this group will receive the standard Sugarbaker parastomal hernia repair, a well-established technique involving the placement of as an IPOM mesh replacement to reinforce the abdominal wall. Receives: Procedure: standard Sugarbecker's operation |
| modified Sugarbecker's operation | Other | patients this group will undergo a modified technique where the mesh is positioned entirely within the extraperitoneal space Receives: Procedure: modified Sugarbecker's operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate of Parastomal Hernia
This outcome measures the rate at which the hernias recur post-surgery after using the laparoscopic total extraperitoneal parastomal hernia repair technique modified from the traditional Sugarbaker's operation. A recurrence constitutes any hernia that reappears in the region of the stoma where the surgery was initially performed.
Measured: 1 year post-operation Ensure that the timelines, definitions, and other details reflect the specific procedures and follow-ups that are planned for the clinical trial being discussed.
Secondary outcomes (5)
Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area
This measure tracks the occurrence of infectious complications at the site of the surgical wound and where the mesh is placed. Such complications include signs of infection at the incision site, such as redness, swelling, and discharge, as well as deeper infections involving the mesh.
Measured: Assessed at post-operative days 1, 3, 7, 14, and during follow-up visits at 1 month, 3 months, and 6 months
Quality of Life Assessment - Short Form Health Survey (SF-36) Score
The SF-36 is a 36-item patient-reported survey of patient health, measuring 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0 to 100, with higher scores indicating better health status/quality of life.
Measured: Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation
Length of Hospital Stay
Tracking the duration from the completion of surgery until discharge to assess the potential impact of the laparoscopic total extraperitoneal approach on recovery times.
Measured: From date of surgery until hospital discharge, assessed up to 30 days
Intra-operative Complications
Monitoring and recording of any complications that occur during the surgery, including but not limited to, bowel injury, bleeding, or unexpected conversion to open surgery.
Measured: During operation
Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain
The VAS is a continuous scale comprised of a horizontal line, 100 mm in length, anchored by two verbal descriptors, one for each symptom extreme (e.g. "no pain" and "worst possible pain"). Patients mark a point on the line that represents their current level of pain. Scores range from 0 (no pain) to 100 (worst possible pain), with higher scores indicating more severe pain.
Measured: Assessed at 24 hours, 72 hours, and 7 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start12 Jan 2024
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This randomized controlled trial aims to assess the efficacy and safety of a modified Sugarbaker technique in the laparoscopic total extraperitoneal repair of parastomal hernias.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474403
- Sponsor's protocol ID
- LTEPPHR - 030524
- Acronym
- LTEPP
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
- ClinicalTrials.gov ID
- NCT06474403
- Acronym / sponsor ID
- LTEPP / LTEPPHR - 030524
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal Hernia, Hernia Recurrence, Minimally Invasive Surgery, Sugabecker's Operation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical HospitalOther government
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
Parastomal herniation presents as a common complication following stomal surgeries, creating significant morbidity and adversely impacting the quality of life for patients. Traditional open surgical techniques, including Sugabecker's operation, offer variable success rates and potential complications. This study proposes an adaptation utilizing a laparoscopic total extraperitoneal (TEP) approach, tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs.
Objective:
The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabecker's operation and to assess its outcomes in terms of feasibility, safety, and hernia recurrence rate.
Brief Protocol Description:
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.
Scientific Hypothesis:
The hypothesis underpinning this research is that a laparoscopic TEP approach to parastomal hernia repair, modifying Sugabecker's procedure, can provide more favorable outcomes, for example: less intraoperative trauma, fewer bowel injuries due to adhesiolysis, and fewer intestinal perforations. Specifically, it is expected that this minimally invasive method will result in a significant reduction in postoperative pain, shorter hospital stays, faster recovery, decreased morbidity, and lower hernia recurrence rates in comparison with the traditional Sugabecker's or Paul's operations.
Expected Results:
This study anticipates that the laparoscopic TEP repair will demonstrate:
- A safe and reproducible procedure adaptable to different hernia sizes and locations around stomas.
- Reduced immediate intra - and postoperative complications, including infections and hematoma formation.
- Quicker patient mobilization and discharge times when compared with the open approach.
- A statistically significant reduction in parastomal hernia recurrence over a long-term follow-up when matched against controls who have undergone traditional Sugabecker's repair.
- High patient satisfaction scores and improved quality of life indicators due to the minimally invasive nature of the repair.
In conclusion, through a detailed analysis of perioperative outcomes, long-term follow-up, and comparative studies with traditional methods, this research aims to establish the laparoscopic TEP approach as a superior modification to parastomal hernia repair, upholding the tenets of enhanced recovery and patient-centered care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized controlled trial aims to assess the efficacy and safety of a modified Sugarbaker technique in the laparoscopic total extraperitoneal repair of parastomal hernias.
| Arm | Type | Receives |
|---|---|---|
| standard Sugarbecker's operation | Other | Procedure: standard Sugarbecker's operationpatients this group will receive the standard Sugarbaker parastomal hernia repair, a well-established technique involving the placement of as an IPOM mesh replacement to reinforce the abdominal wall. |
| modified Sugarbecker's operation | Other | Procedure: modified Sugarbecker's operationpatients this group will undergo a modified technique where the mesh is positioned entirely within the extraperitoneal space |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard Sugarbecker's operationEligible 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. | Procedure or surgery | standard Sugarbecker's operation |
| modified Sugarbecker's operationEligible 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. | Procedure or surgery | modified Sugarbecker's operation |
Primary outcome
Recurrence Rate of Parastomal Hernia
Time frame: 1 year post-operation Ensure that the timelines, definitions, and other details reflect the specific procedures and follow-ups that are planned for the clinical trial being discussed.
This outcome measures the rate at which the hernias recur post-surgery after using the laparoscopic total extraperitoneal parastomal hernia repair technique modified from the traditional Sugarbaker's operation. A recurrence constitutes any hernia that reappears in the region of the stoma where the surgery was initially performed.
5 secondary outcomes
Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area
Time frame: Assessed at post-operative days 1, 3, 7, 14, and during follow-up visits at 1 month, 3 months, and 6 months
Quality of Life Assessment - Short Form Health Survey (SF-36) Score
Time frame: Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation
Length of Hospital Stay
Time frame: From date of surgery until hospital discharge, assessed up to 30 days
Intra-operative Complications
Time frame: During operation
Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain
Time frame: Assessed at 24 hours, 72 hours, and 7 days post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard Sugarbecker's operation and modified Sugarbecker's operation in people with Parastomal Hernia, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr Petrovsky, MD, PhD (+79094648456, a_petrovsky@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate of Parastomal Hernia (time frame: 1 year post-operation Ensure that the timelines, definitions, and other details reflect the specific procedures and follow-ups that are planned for the clinical trial being discussed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.