Endometriosis, RectumNCT04398641
Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
An observational study of Endometriosis, Rectum, run by Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc. at 2 sites in Austria.
Trial summary
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Rectum
- What is being tested?
- Evaluation of pre- and postoperative gastrointestinal functional outcomes
- How many people
- 300 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jul 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge will be included in this study. These women will undergo either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE).
Who may be able to join
- Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge
Who cannot join
- Diagnosed or suspected malignancy
- Previous colorectal surgery
- Previous history of chronic inflammatory diseases of the gastrointestinal tract and/or chronic defecation dysfunction related to other factors such as birth trauma etc.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Woman & Health Vienna
Vienna, 1010
Gernot Hudelist, MD, MSc
- Recruiting
Hospital St. John of God Vienna
Vienna, 1020
Gernot Hudelist, MD, MSc
About this study
Official title: Surgery for Deep Endometriosis of the Lower Rectum (Segmental/Disc) - a Prospective Comparison of Surgical Techniques Regarding Pre- and Postoperative Digestive Symptoms and Pain Outcomes
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery with typical symptoms such as constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described as low anterior resection syndrome (LARS).
The primary aim of this study is the prospective comparison of two surgical approaches for full thickness excision, i.e. transanal disc excision (TADE) and nerve-vessel sparing limited segmental resection (NVSSR), regarding gastrointestinal functional outcomes using the LARS / Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaires.
Read the detailed description
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, there is inceasing evidence that intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery for rectal deep endometriosis (DE). Typical symptoms include constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described in the colorectal surgical literature as low anterior resection syndrome (LARS). The choice of operation is largely dependent on the extent of disease. Statistically significant differences in functional outcomes were found in favor of the conservative surgical approach, i.e. resection of endometriotic tissue with preservation of the luminal structure of the rectal wall thereby avoiding segmental bowel resection. In a recent retrospective multicentric cohort analysis, the incidence of LARS after either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE) performed for the surgical treatment of colorectal DE was assessed. All patients underwent a low rectum resection, with a resection line lower than 7cm from anal verge. In contrast to previoisly published data, no statistically significant difference between the incidence of the LARS among patients operated using TADE when compared to women treated by NVSSR were found. Interestingly, the occurence of LARS was positively associated with the use of protective ileo-or colostomy. A higher rate of severe complications was observed in the TADE group than among patients who underwent a NVSSR. Weaknesses of this study are the retrospective design and a possible bias in the TADE regarding larger DE nodules as well as the possibility of bowel dysfunction prior to surgery in women with DE.
The primary aim of the present study is the prospective comparison of two surgical approaches for full thickness excision of rectal DE resulting in an anastomotic height ≤7 cm distance from the anal verge. One technique involves the preservation of the residual luminal wall integrity (disc resection) known as Rouen technique/ TADE. The other technique involves limited resection of the bowel wall with preservation of all adjacent structures (autonomic pelvic plexus, rectal vascular supply) known as NVSSR. Gastrointestinal functional outcomes of the two procedures will be compared using the LARS / GIQLI by Eypasch questionnaires. Since digestive complaints may also be present presurgically, evaluation of digestive complaints will be recorded pre- and post surgery.
- Conditions
- Endometriosis, Rectum
- Being tested
- Evaluation of pre- and postoperative gastrointestinal functional outcomes
- Keywords
- Bowel endometriosis, Deep endometriosis (DE), Transanal disc excision (TADE), Nerve and vessel sparing segmental resection (NVSSR), Low Anterior Resection Syndrome (LARS), Digestive complaints, Gastrointestinal Quality of Life Index (GIQLI) by Eypasch
- Medical subject headings
- Endometriosis, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of pre- and postoperative gastrointestinal functional outcomesOther
Gastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Nerve and vessel sparing segmental resection (NVSSR) | Women undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of nerve and vessel sparing segmental resection (NVSSR) Receives: Other: Evaluation of pre- and postoperative gastrointestinal functional outcomes | |
| Transanal disc excision (TADE) | Women undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of transanal disc excision (TADE) Receives: Other: Evaluation of pre- and postoperative gastrointestinal functional outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of gastrointestinal functional outcomes between groups using the LARS questionnaire
Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Low Anterior Resection Syndrome (LARS) questionnaire.
LARS questionnaire: scores range from a minimum of 0 to a maximum of 42 points; higher scores mean a worse outcome
Measured: 4 to 24 months
Comparison of gastrointestinal functional outcomes between groups using the GIQLI by Eypasch questionnaire
Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaire.
GIQLI by Eypasch questionnaire: scores range from a minimum of 0 to a maximum of 144 points; higher scores mean a better outcome
Measured: 4 to 24 months
Secondary outcomes (2)
Prevalence of presurgical digestive complaints (LARS)
The prevalence of presurgical digestive complaints assessed using the LARS questionnaire will be evaluated.
Measured: 1 day
Prevalence of presurgical digestive complaints (GIQLI by Eypasch)
The prevalence of presurgical digestive complaints assessed using the GIQLI by Eypasch questionnaire will be evaluated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jul 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, RectumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc., Woman and Health Private Clinic Vienna
- Investigators
- Gernot Hudelist, MD, MSc, Principal investigator, Woman & Health Private Clinic Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398641
- Sponsor's protocol ID
- 2
- Status last verified
- Oct 2021
- First submitted
- 18 May 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Deep Endometriosis of the Lower Rectum (Segmental/Disc) - a Prospective Comparison of Surgical Techniques Regarding Pre- and Postoperative Digestive Symptoms and Pain Outcomes
- ClinicalTrials.gov ID
- NCT04398641
- Acronym / sponsor ID
- 2
- Conditions
- Endometriosis, Rectum
- Keywords
- Bowel endometriosis, Deep endometriosis (DE), Transanal disc excision (TADE), Nerve and vessel sparing segmental resection (NVSSR), Low Anterior Resection Syndrome (LARS), Digestive complaints, Gastrointestinal Quality of Life Index (GIQLI) by Eypasch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.University, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 21 May 2020 (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.
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery with typical symptoms such as constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described as low anterior resection syndrome (LARS).
The primary aim of this study is the prospective comparison of two surgical approaches for full thickness excision, i.e. transanal disc excision (TADE) and nerve-vessel sparing limited segmental resection (NVSSR), regarding gastrointestinal functional outcomes using the LARS / Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaires.
Detailed description
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, there is inceasing evidence that intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery for rectal deep endometriosis (DE). Typical symptoms include constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described in the colorectal surgical literature as low anterior resection syndrome (LARS). The choice of operation is largely dependent on the extent of disease. Statistically significant differences in functional outcomes were found in favor of the conservative surgical approach, i.e. resection of endometriotic tissue with preservation of the luminal structure of the rectal wall thereby avoiding segmental bowel resection. In a recent retrospective multicentric cohort analysis, the incidence of LARS after either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE) performed for the surgical treatment of colorectal DE was assessed. All patients underwent a low rectum resection, with a resection line lower than 7cm from anal verge. In contrast to previoisly published data, no statistically significant difference between the incidence of the LARS among patients operated using TADE when compared to women treated by NVSSR were found. Interestingly, the occurence of LARS was positively associated with the use of protective ileo-or colostomy. A higher rate of severe complications was observed in the TADE group than among patients who underwent a NVSSR. Weaknesses of this study are the retrospective design and a possible bias in the TADE regarding larger DE nodules as well as the possibility of bowel dysfunction prior to surgery in women with DE.
The primary aim of the present study is the prospective comparison of two surgical approaches for full thickness excision of rectal DE resulting in an anastomotic height ≤7 cm distance from the anal verge. One technique involves the preservation of the residual luminal wall integrity (disc resection) known as Rouen technique/ TADE. The other technique involves limited resection of the bowel wall with preservation of all adjacent structures (autonomic pelvic plexus, rectal vascular supply) known as NVSSR. Gastrointestinal functional outcomes of the two procedures will be compared using the LARS / GIQLI by Eypasch questionnaires. Since digestive complaints may also be present presurgically, evaluation of digestive complaints will be recorded pre- and post surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve and vessel sparing segmental resection (NVSSR) | – | Other: Evaluation of pre- and postoperative gastrointestinal functional outcomesWomen undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of nerve and vessel sparing segmental resection (NVSSR) |
| Transanal disc excision (TADE) | – | Other: Evaluation of pre- and postoperative gastrointestinal functional outcomesWomen undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of transanal disc excision (TADE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge will be included in this study. These women will undergo either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE).
Key inclusion criteria (1 listed)
- Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge
Key exclusion criteria (3 listed)
- Diagnosed or suspected malignancy
- Previous colorectal surgery
- Previous history of chronic inflammatory diseases of the gastrointestinal tract and/or chronic defecation dysfunction related to other factors such as birth trauma etc.
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 |
|---|---|---|
| Evaluation of pre- and postoperative gastrointestinal functional outcomesGastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires. | Other | Nerve and vessel sparing segmental resection (NVSSR), Transanal disc excision (TADE) |
Primary outcome
Comparison of gastrointestinal functional outcomes between groups using the LARS questionnaire
Time frame: 4 to 24 months
Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Low Anterior Resection Syndrome (LARS) questionnaire. LARS questionnaire: scores range from a minimum of 0 to a maximum of 42 points; higher scores mean a worse outcome
Comparison of gastrointestinal functional outcomes between groups using the GIQLI by Eypasch questionnaire
Time frame: 4 to 24 months
Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaire. GIQLI by Eypasch questionnaire: scores range from a minimum of 0 to a maximum of 144 points; higher scores mean a better outcome
2 secondary outcomes
Prevalence of presurgical digestive complaints (LARS)
Time frame: 1 day
Prevalence of presurgical digestive complaints (GIQLI by Eypasch)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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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. This study is not recruiting at the moment.
Gernot Hudelist, MD, MSc principal investigator
Woman & Health Private Clinic Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, Rectum, run by Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc. at 2 sites in Austria.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gernot Hudelist, MD, MSc (0043 1 5333 654, gernot.hudelist@womanandhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of gastrointestinal functional outcomes between groups using the LARS questionnaire (time frame: 4 to 24 months). The study lists 2 primary outcomes in all. 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 8 Oct 2021.