Slow Transit ConstipationNCT05352074
STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
A study testing Total colectomy with ileorectal anastomosis and Subtotal colectomy with cecal-rectal anastomosis in people with Slow Transit Constipation and Surgery, run by Third Military Medical University at 14 sites in China.
Trial summary
Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Slow Transit Constipation, Surgery
- What is being tested?
- Total colectomy with ileorectal anastomosis and Subtotal colectomy with cecal-rectal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 14 sitesChina
- Study dates
- 27 Mar 2022to 1 May 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (≥18 years of age) of either sex
- Patients with conditions in agreement with the Roman IV criteria of functional constipation
- Patients have less than one complete spontaneous bowel movement per week
- Patients rely on laxatives to assist defecation for a long time
- More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
- Patients were refractory to conservative treatment for more than 1 year
- Patients with a strong desire for surgery
Who cannot join
- Pregnant or breast-feeding women
- Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
- Patients with colorectal neoplasms
- Patients with small intestinal slow transit
- Patients with constipation-predominant irritable bowel syndrome
- Patients with inflammatory bowel disease
- Patients with ileostomy
- Patients with severe psychiatric disease
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Chengdu Analrectal Hospital
Chengdu, Sichuan, 610017
The General Hospital of Western Theater Command
Chengdu, Sichuan, 610036
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
Lanzhou, Gansu, 730050
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, 210002
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, 200127
Shanghai Pudong New Area People's Hospital
Pudong, Shanghai Municipality, 201299
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
The First Hospital of China Medical University
Shengyang, Liaoning, 110001
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
Xijing Hospital
Xi’an, Shanxi, 710032
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, 400042
About this study
Official title: STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation
Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.
Read the detailed description
Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.
- Conditions
- Slow Transit Constipation, Surgery
- Being tested
- Total colectomy with ileorectal anastomosis, Subtotal colectomy with cecal-rectal anastomosis
- Keywords
- Slow Transit Constipation, Total Colectomy with Ileorectal Anastomosis, Subtotal Colectomy with Caecorectal Anastomosis, Defecation Function, Quality of Life, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total colectomy with ileorectal anastomosisProcedure or surgery
Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.
Subtotal colectomy with cecal-rectal anastomosisProcedure or surgery
Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.
| Study group | Role | What they receive |
|---|---|---|
| Total colectomy with ileorectal anastomosis | Active comparator | Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation. Receives: Procedure: Total colectomy with ileorectal anastomosis |
| Subtotal colectomy with cecal-rectal anastomosis | Experimental | Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation. Receives: Procedure: Subtotal colectomy with cecal-rectal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wexner Constipation Score
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
Measured: From the pre-operation to 36 months following surgery
Secondary outcomes (12)
Gastrointestinal Quality of Life Index
Gastrointestinal Quality of Life Index will be recorded in terms of scores. There are The four possible answers to every question, scored from 0 points (worst) to 4 points (best). The final sum ranges from 0(worst) to 144(best).
Measured: From the pre-operation to 36 months following surgery
36-item short-form health survey
There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores. Once the questionnaire was applied to the patients, a summary calculation and a linear transformation were performed to obtain a score within a scale from 0(worst) to 100(best).
Measured: From the pre-operation to 36 months following surgery
The incidence of complications
Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.
Measured: From the pre-operation to 36 months following surgery
The number of bowel movements per week
The number of bowel movements will be recorded in terms of times per week.
Measured: From the pre-operation to 36 months following surgery
Wexner's incontinence score
The Wexner's incontinence score will be recorded in terms of scores. the sacles have 5 items to quantify incontinence grade and frequency and its effect on ordinary life. Each question is answered on a scale of 0 to 4, the global score ranging from 0 (best) to 20 (worst).
Measured: From the pre-operation to 36 months following surgery
The incidence of abdominal pain
The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.
Measured: From the pre-operation to 36 months following surgery
The incidence of bloating
The incidence of bloating will be recorded in terms of percent
Measured: From the pre-operation to 36 months following surgery
The incidence of diarrhea
The incidence of diarrhea will be recorded in terms of percent.
Measured: From the pre-operation to 36 months following surgery
The incidence of straining
The incidence of straining will be recorded in terms of percent.
Measured: From the pre-operation to 36 months following surgery
The incidence of laxative use
The incidence of laxative use will be recorded in terms of percent.
Measured: From the pre-operation to 36 months following surgery
The incidence of enema use
The incidence of enema use use will be recorded in terms of percent.
Measured: From the pre-operation to 36 months following surgery
Intraoperative measures
Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start27 Mar 2022
- Primary completion1 May 2025
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Slow Transit ConstipationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Study director, Army Medical Center (Daping Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352074
- Sponsor's protocol ID
- 20211114
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.
PubMed 30948148Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
PubMed 25887580Perivoliotis K, Baloyiannis I, Tzovaras G. Cecorectal (CRA) versus ileorectal (IRA) anastomosis after colectomy for slow transit constipation (STC): a meta-analysis. Int J Colorectal Dis. 2022 Mar;37(3):531-539. doi: 10.1007/s00384-022-04093-y. Epub 2022 Jan 12.
PubMed 35020001Knowles CH, Grossi U, Horrocks EJ, Pares D, Vollebregt PF, Chapman M, Brown S, Mercer-Jones M, Williams AB, Yiannakou Y, Hooper RJ, Stevens N, Mason J; NIHR CapaCiTY working group; Pelvic floor Society and; European Society of Coloproctology. Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations. Colorectal Dis. 2017 Sep;19 Suppl 3:101-113. doi: 10.1111/codi.13775.
PubMed 28960922Deng XM, Zhu TY, Wang GJ, Gao BL, Li RX, Wang JT. Laparoscopic total colectomy with ileorectal anastomosis and subtotal colectomy with antiperistaltic cecorectal anastomosis for slow transit constipation. Updates Surg. 2023 Jun;75(4):871-880. doi: 10.1007/s13304-023-01458-y. Epub 2023 Mar 14.
PubMed 36914915Guo M, Li F, Bu F, Cui Z, Lan H, Ni L, Gao F, Wang Y, Zhou J, Fu T, Liu W, Xu D, Liu X, Gao H, Huang B, Wang L, Zhang L, Wu M, Jiang C, Jiang J, Gong W, Tong W; STOPS Study Group. Subtotal Colectomy vs Total Colectomy for Slow-Transit Constipation: 1-Year Outcomes of the STOPS Randomized Clinical Trial. JAMA Surg. 2026 Oct 21:e264932. doi: 10.1001/jamasurg.2026.4932. Online ahead of print.
PubMed 42905730Tian Y, Guo M, Bu F, Ni L, Liu W, Gao F, Lan H, Cui Z, Fu T, Wang Y, Li F, Xu D, Gao H, Zhang L, Liu X, Huang B, Wang L, Jiang C, Jiang J, Gong W, Tong W. Total colectomy with ileorectal anastomosis versus subtotal colectomy with cecal-rectal anastomosis for slow transit constipation: protocol for a multicenter randomized controlled trial (STOPS trial). Trials. 2025 Oct 10;26(1):402. doi: 10.1186/s13063-025-09049-5.
PubMed 41074220
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation
- ClinicalTrials.gov ID
- NCT05352074
- Acronym / sponsor ID
- 20211114
- Conditions
- Slow Transit Constipation, Surgery
- Keywords
- Slow Transit Constipation, Total Colectomy with Ileorectal Anastomosis, Subtotal Colectomy with Caecorectal Anastomosis, Defecation Function, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 28 Apr 2022 (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.
Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.
Detailed description
Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total colectomy with ileorectal anastomosis | Active comparator | Procedure: Total colectomy with ileorectal anastomosisTotal colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation. |
| Subtotal colectomy with cecal-rectal anastomosis | Experimental | Procedure: Subtotal colectomy with cecal-rectal anastomosisSubtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients (≥18 years of age) of either sex
- Patients with conditions in agreement with the Roman IV criteria of functional constipation
- Patients have less than one complete spontaneous bowel movement per week
- Patients rely on laxatives to assist defecation for a long time
- More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women
- Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
- Patients with colorectal neoplasms
- Patients with small intestinal slow transit
- Patients with constipation-predominant irritable bowel syndrome
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 |
|---|---|---|
| Total colectomy with ileorectal anastomosisFollowing complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers. | Procedure or surgery | Total colectomy with ileorectal anastomosis |
| Subtotal colectomy with cecal-rectal anastomosisFollowing complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion. | Procedure or surgery | Subtotal colectomy with cecal-rectal anastomosis |
Primary outcome
Wexner Constipation Score
Time frame: From the pre-operation to 36 months following surgery
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
12 secondary outcomes
Gastrointestinal Quality of Life Index
Time frame: From the pre-operation to 36 months following surgery
36-item short-form health survey
Time frame: From the pre-operation to 36 months following surgery
The incidence of complications
Time frame: From the pre-operation to 36 months following surgery
The number of bowel movements per week
Time frame: From the pre-operation to 36 months following surgery
Wexner's incontinence score
Time frame: From the pre-operation to 36 months following surgery
The incidence of abdominal pain
Time frame: From the pre-operation to 36 months following surgery
The incidence of bloating
Time frame: From the pre-operation to 36 months following surgery
The incidence of diarrhea
Time frame: From the pre-operation to 36 months following surgery
The incidence of straining
Time frame: From the pre-operation to 36 months following surgery
The incidence of laxative use
Time frame: From the pre-operation to 36 months following surgery
The incidence of enema use
Time frame: From the pre-operation to 36 months following surgery
Intraoperative measures
Time frame: Perioperative period
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 14 Apr 2026.
- Results publication: PubMed 30948148Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.
- Results publication: PubMed 25887580Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
- Results publication: PubMed 35020001Perivoliotis K, Baloyiannis I, Tzovaras G. Cecorectal (CRA) versus ileorectal (IRA) anastomosis after colectomy for slow transit constipation (STC): a meta-analysis. Int J Colorectal Dis. 2022 Mar;37(3):531-539. doi: 10.1007/s00384-022-04093-y. Epub 2022 Jan 12.
- Results publication: PubMed 28960922Knowles CH, Grossi U, Horrocks EJ, Pares D, Vollebregt PF, Chapman M, Brown S, Mercer-Jones M, Williams AB, Yiannakou Y, Hooper RJ, Stevens N, Mason J; NIHR CapaCiTY working group; Pelvic floor Society and; European Society of Coloproctology. Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations. Colorectal Dis. 2017 Sep;19 Suppl 3:101-113. doi: 10.1111/codi.13775.
- Results publication: PubMed 36914915Deng XM, Zhu TY, Wang GJ, Gao BL, Li RX, Wang JT. Laparoscopic total colectomy with ileorectal anastomosis and subtotal colectomy with antiperistaltic cecorectal anastomosis for slow transit constipation. Updates Surg. 2023 Jun;75(4):871-880. doi: 10.1007/s13304-023-01458-y. Epub 2023 Mar 14.
- Derived from this study: PubMed 42905730Guo M, Li F, Bu F, Cui Z, Lan H, Ni L, Gao F, Wang Y, Zhou J, Fu T, Liu W, Xu D, Liu X, Gao H, Huang B, Wang L, Zhang L, Wu M, Jiang C, Jiang J, Gong W, Tong W; STOPS Study Group. Subtotal Colectomy vs Total Colectomy for Slow-Transit Constipation: 1-Year Outcomes of the STOPS Randomized Clinical Trial. JAMA Surg. 2026 Oct 21:e264932. doi: 10.1001/jamasurg.2026.4932. Online ahead of print.
- Derived from this study: PubMed 41074220Tian Y, Guo M, Bu F, Ni L, Liu W, Gao F, Lan H, Cui Z, Fu T, Wang Y, Li F, Xu D, Gao H, Zhang L, Liu X, Huang B, Wang L, Jiang C, Jiang J, Gong W, Tong W. Total colectomy with ileorectal anastomosis versus subtotal colectomy with cecal-rectal anastomosis for slow transit constipation: protocol for a multicenter randomized controlled trial (STOPS trial). Trials. 2025 Oct 10;26(1):402. doi: 10.1186/s13063-025-09049-5.
- Individual participant dataSharing planned: No
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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.
Weidong Tong, MD study director
Army Medical Center (Daping Hospital)
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total colectomy with ileorectal anastomosis and Subtotal colectomy with cecal-rectal anastomosis in people with Slow Transit Constipation and Surgery, run by Third Military Medical University at 14 sites in China.
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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. 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?
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?
Wexner Constipation Score (time frame: From the pre-operation to 36 months following surgery). 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 NCT05352074, which also lists 7 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 14 Apr 2026.