Ulcerative Colitis (Disorder)LATA-IBDNCT07278687
LATA-IBD TRIAL a Controlled Feasibility Study for the Introduction of Transanal Minimally Invasive IPAA-Surgery. Evaluation of Operative Results and Bowel Function After Introducing Transanal IPAA-surgery to Replace Conventional Laparoscopic IPAA-surgery.
An observational study of Ulcerative Colitis (Disorder) and Familial Adenomatous Polyposis (FAP), run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
This study compares the operative and functional outcomes of adding a transanal pathway to laparoscopic pelvic pouch surgery. The transanal pathway enables the surgeon to have better control when dividing the rectum and it may improve visualization in pelvic dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (Disorder), Familial Adenomatous Polyposis (FAP)
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 18 Apr 2018to 30 Mar 2023
- How long will I take part?
- 2 Years
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients aged >18 years with a diagnosis of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) scheduled for lap-IPAA between 2018 and 2020 at Sahlgrenska University Hospital were invited to participate. A minimum sample size of 20 patients was considered sufficient to evaluate the feasibility of introducing the ta-IPAA technique. For comparison, a historical control group of 17 patients who underwent lap-IPAA between 2015 and 2016 was identified.
Who may be able to join
- 18 years and over.
- UC or FAP.
- Fit for laparoscopic IPAA-surgery
- Signed informed consent.
Who cannot join
- Not meeeting inclusion criteria above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LATA-IBD Trial a Laparoscopic and Transanal IPAA-surgery Trial.
This study compares the operative and functional outcomes of adding a transanal pathway to laparoscopic pelvic pouch surgery. The transanal pathway enables the surgeon to have better control when dividing the rectum and it may improve visualization in pelvic dissection. This could decrease the need for conversion to open surgery, reduce complications, postoperative pain, hospital stay and improve bowel function after surgery. The study compares two consecutive groups of patients at a single institution. The transanally operated group consists of 22 patients with prospectively collected data between 2018-2020 and the traditional laparoscopic group consists of 17 patients with retrospectively collected data operated between 2015-2016. Inclusion criteria for the transanal group were patients over 18 years with either ulcerative colitis or familial adenomatous polyposis who were possible to operate with laparoscopic surgery and who had signed an informed consent.
The studys primary objective is to investigate if there is a difference in the frequency of conversions to open surgery or anastomotic leakage of the anastomosis between the pelvic pouch and the anal canal. Secondary objectives are mortality, bleeding, operative time, complications, reoperations, hospital stay, readmissions to hospital and bowel function two years after surgery.
Read the detailed description
Study Design This is a prospective feasibility study comparing consecutive patients undergoing ta-IPAA with a historical cohort of patients treated with lap-IPAA at the same institution.
Endpoints The primary endpoints were conversion rate and anastomotic leakage rate. Conversion was defined as the need for laparotomy before pouch construction and/or specimen extraction, or the requirement to extend or alter the initial incision during pouch construction. Anastomotic leakage was defined and graded according to the International Study Group of Rectal Cancer (18).
Secondary endpoints included mortality, intraoperative bleeding, operative time, postoperative complications (graded according to the Clavien Dindo classification (19)), reoperations, readmissions, length of hospital stay and pouch function. Pouch function was assessed using the Öresland score (OS) (20) two years after surgery. The OS consists of 11 parameters measuring bowel function after IPAA and ranges from 0-15 (higher scores indicate worse function). Scores ≥8 are associated with impaired pouch function and reduced quality of life. Pouch failure was defined as the need for a diverting stoma or excision of the pouch.
Data collection Study data were collected prospectively using a paper case report form (CRFs) completed at predefined time points: preoperatively, intraoperatively, at hospital discharge and 3, 6, 12 and 24 months after ta-IPAA. For the historical control group, data were retrieved retrospectively from medical records. Intraoperative data were excluded from the lap-IPAA group, as these could not be reliably retrieved.
Training The surgical team consisted of three colorectal surgeons and experienced operating room nurses, all with prior expertise in laparoscopic Total Mesorectal Excision (TME) and IPAA-surgery. The team underwent formal training in taTME-surgery, including participation in dedicated courses, observational visits and on-site proctoring by an international center with significant experience in ta-IPAA.
Surgical Procedure The procedure began with takedown of the loop ileostomy. If mesenteric length was sufficient, the pouch was constructed immediately; otherwise, pouch construction was delayed until the abdominal phase, using either a midline or suprapubic incision. The abdomen was insufflated, and the mesentary was freed from adhesions and the duodenum. Mesenteric lengthening techniques were applied as required before constructing the ileal pouch.
Rectal dissection was performed in a modified TME plane, remaining closer to the rectum, particularly anteriorly, for the first two-thirds of the dissection. The transanal approach was used for the final third, employing standard equipment including the GelPOINT Path Transanal Access Platform®, Lone Star retractor®, and AirSeal® System. Dissection was performed with monopolar cautery, and the purse-string suture was placed with 3-0 V-Loc®. The rectum was extracted transanally or, if necessary, via an abdominal incision. The ileoanal anastomosis was constructed with a circular stapler, and a diverting stoma was created at the previous ileostomy site. (21)
- Keywords
- ulcerative colitis, laparoscopy, transanal surgery, pelvic pouch
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 22 Patients operated with transanal laparoscopic IPAA | Proaspecticely collected data with paper case report form | |
| 17 Patients operated with conventional laparoscopic IPAA | Retrospectively collected data from medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate to open surgery
Rate of patients with abdominal incision before pouch construction or changed or extended abdominal incision during pouch construction.
Measured: During surgery
Anastomotic leakage rate
Rate of anastomotic leakage as defined by the international study group of cancer. A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments.
Measured: Within 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start18 Apr 2018
- Primary completion31 Jan 2021
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (Disorder)Studies 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
- 39 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjarne Melvas, Sahlgrenska University Hospital
- Investigators
- Hanna de la Croix, Associate professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278687
- Sponsor's protocol ID
- Dnr 2024-03692-02
- Acronym
- LATA-IBD
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data may be shared if needed but only if the secrecy of the patients is maintained. Data will be presented as group data in the publication.
Publications
Deng SX, Brar MS, Yang ML, Park JJ, de Buck van Overstraeten A. Functional outcomes of transanal ileal pouch anal anastomosis in patients with ulcerative colitis: inverse-probability weighing analysis of a single-center cohort. J Gastrointest Surg. 2025 Oct;29(10):102189. doi: 10.1016/j.gassur.2025.102189. Epub 2025 Aug 13.
PubMed 40816645Stephens IJB, Byrnes KG, Burke JP. Transanal ileal pouch-anal anastomosis: A systematic review and meta-analysis of technical approaches and clinical outcomes. Langenbecks Arch Surg. 2024 May 6;409(1):153. doi: 10.1007/s00423-024-03343-7.
PubMed 38705912de Buck van Overstraeten A, Mark-Christensen A, Wasmann KA, Bastiaenen VP, Buskens CJ, Wolthuis AM, Vanbrabant K, D'hoore A, Bemelman WA, Tottrup A, Tanis PJ. Transanal Versus Transabdominal Minimally Invasive (Completion) Proctectomy With Ileal Pouch-anal Anastomosis in Ulcerative Colitis: A Comparative Study. Ann Surg. 2017 Nov;266(5):878-883. doi: 10.1097/SLA.0000000000002395.
PubMed 28742696Violante T, Broccard SP, Novelli M, Stocchi L, Colibaseanu DT, DeLeon MF, Behm KT, Mishra N, Larson DW, Merchea A. Comparative analysis of robotic, laparoscopic, and open ileal pouch-anal anastomosis outcomes: retrospective cohort study. BJS Open. 2025 Jul 1;9(4):zraf084. doi: 10.1093/bjsopen/zraf084.
PubMed 40742352
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LATA-IBD Trial a Laparoscopic and Transanal IPAA-surgery Trial.
- ClinicalTrials.gov ID
- NCT07278687
- Acronym / sponsor ID
- LATA-IBD / Dnr 2024-03692-02
- Keywords
- ulcerative colitis, laparoscopy, transanal surgery, pelvic pouch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 12 Dec 2025 (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.
This study compares the operative and functional outcomes of adding a transanal pathway to laparoscopic pelvic pouch surgery. The transanal pathway enables the surgeon to have better control when dividing the rectum and it may improve visualization in pelvic dissection. This could decrease the need for conversion to open surgery, reduce complications, postoperative pain, hospital stay and improve bowel function after surgery. The study compares two consecutive groups of patients at a single institution. The transanally operated group consists of 22 patients with prospectively collected data between 2018-2020 and the traditional laparoscopic group consists of 17 patients with retrospectively collected data operated between 2015-2016. Inclusion criteria for the transanal group were patients over 18 years with either ulcerative colitis or familial adenomatous polyposis who were possible to operate with laparoscopic surgery and who had signed an informed consent.
The studys primary objective is to investigate if there is a difference in the frequency of conversions to open surgery or anastomotic leakage of the anastomosis between the pelvic pouch and the anal canal. Secondary objectives are mortality, bleeding, operative time, complications, reoperations, hospital stay, readmissions to hospital and bowel function two years after surgery.
Detailed description
Study Design This is a prospective feasibility study comparing consecutive patients undergoing ta-IPAA with a historical cohort of patients treated with lap-IPAA at the same institution.
Endpoints The primary endpoints were conversion rate and anastomotic leakage rate. Conversion was defined as the need for laparotomy before pouch construction and/or specimen extraction, or the requirement to extend or alter the initial incision during pouch construction. Anastomotic leakage was defined and graded according to the International Study Group of Rectal Cancer (18).
Secondary endpoints included mortality, intraoperative bleeding, operative time, postoperative complications (graded according to the Clavien Dindo classification (19)), reoperations, readmissions, length of hospital stay and pouch function. Pouch function was assessed using the Öresland score (OS) (20) two years after surgery. The OS consists of 11 parameters measuring bowel function after IPAA and ranges from 0-15 (higher scores indicate worse function). Scores ≥8 are associated with impaired pouch function and reduced quality of life. Pouch failure was defined as the need for a diverting stoma or excision of the pouch.
Data collection Study data were collected prospectively using a paper case report form (CRFs) completed at predefined time points: preoperatively, intraoperatively, at hospital discharge and 3, 6, 12 and 24 months after ta-IPAA. For the historical control group, data were retrieved retrospectively from medical records. Intraoperative data were excluded from the lap-IPAA group, as these could not be reliably retrieved.
Training The surgical team consisted of three colorectal surgeons and experienced operating room nurses, all with prior expertise in laparoscopic Total Mesorectal Excision (TME) and IPAA-surgery. The team underwent formal training in taTME-surgery, including participation in dedicated courses, observational visits and on-site proctoring by an international center with significant experience in ta-IPAA.
Surgical Procedure The procedure began with takedown of the loop ileostomy. If mesenteric length was sufficient, the pouch was constructed immediately; otherwise, pouch construction was delayed until the abdominal phase, using either a midline or suprapubic incision. The abdomen was insufflated, and the mesentary was freed from adhesions and the duodenum. Mesenteric lengthening techniques were applied as required before constructing the ileal pouch.
Rectal dissection was performed in a modified TME plane, remaining closer to the rectum, particularly anteriorly, for the first two-thirds of the dissection. The transanal approach was used for the final third, employing standard equipment including the GelPOINT Path Transanal Access Platform®, Lone Star retractor®, and AirSeal® System. Dissection was performed with monopolar cautery, and the purse-string suture was placed with 3-0 V-Loc®. The rectum was extracted transanally or, if necessary, via an abdominal incision. The ileoanal anastomosis was constructed with a circular stapler, and a diverting stoma was created at the previous ileostomy site. (21)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22 Patients operated with transanal laparoscopic IPAA | – | –Proaspecticely collected data with paper case report form |
| 17 Patients operated with conventional laparoscopic IPAA | – | –Retrospectively collected data from medical records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients aged >18 years with a diagnosis of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) scheduled for lap-IPAA between 2018 and 2020 at Sahlgrenska University Hospital were invited to participate. A minimum sample size of 20 patients was considered sufficient to evaluate the feasibility of introducing the ta-IPAA technique. For comparison, a historical control group of 17 patients who underwent lap-IPAA between 2015 and 2016 was identified.
Key inclusion criteria (4 listed)
- 18 years and over.
- UC or FAP.
- Fit for laparoscopic IPAA-surgery
- Signed informed consent.
Key exclusion criteria (1 listed)
- Not meeeting inclusion criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conversion rate to open surgery
Time frame: During surgery
Rate of patients with abdominal incision before pouch construction or changed or extended abdominal incision during pouch construction.
Anastomotic leakage rate
Time frame: Within 24 months after surgery
Rate of anastomotic leakage as defined by the international study group of cancer. A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 40816645Deng SX, Brar MS, Yang ML, Park JJ, de Buck van Overstraeten A. Functional outcomes of transanal ileal pouch anal anastomosis in patients with ulcerative colitis: inverse-probability weighing analysis of a single-center cohort. J Gastrointest Surg. 2025 Oct;29(10):102189. doi: 10.1016/j.gassur.2025.102189. Epub 2025 Aug 13.
- Background: PubMed 38705912Stephens IJB, Byrnes KG, Burke JP. Transanal ileal pouch-anal anastomosis: A systematic review and meta-analysis of technical approaches and clinical outcomes. Langenbecks Arch Surg. 2024 May 6;409(1):153. doi: 10.1007/s00423-024-03343-7.
- Background: PubMed 28742696de Buck van Overstraeten A, Mark-Christensen A, Wasmann KA, Bastiaenen VP, Buskens CJ, Wolthuis AM, Vanbrabant K, D'hoore A, Bemelman WA, Tottrup A, Tanis PJ. Transanal Versus Transabdominal Minimally Invasive (Completion) Proctectomy With Ileal Pouch-anal Anastomosis in Ulcerative Colitis: A Comparative Study. Ann Surg. 2017 Nov;266(5):878-883. doi: 10.1097/SLA.0000000000002395.
- Background: PubMed 40742352Violante T, Broccard SP, Novelli M, Stocchi L, Colibaseanu DT, DeLeon MF, Behm KT, Mishra N, Larson DW, Merchea A. Comparative analysis of robotic, laparoscopic, and open ileal pouch-anal anastomosis outcomes: retrospective cohort study. BJS Open. 2025 Jul 1;9(4):zraf084. doi: 10.1093/bjsopen/zraf084.
- Individual participant dataSharing planned: Undecided. Individual patient data may be shared if needed but only if the secrecy of the patients is maintained. Data will be presented as group data in the publication.
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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.
Hanna de la Croix, Associate professor principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (Disorder) and Familial Adenomatous Polyposis (FAP), run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Dec 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate to open surgery (time frame: During surgery). 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?
On the ClinicalTrials.gov record for NCT07278687, which also lists 4 linked publications.
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 12 Dec 2025.