CClinicalTrials.gg
Active, not recruitingNCT05352074Updated Apr 14, 2026

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

An interventional study of Total colectomy with ileorectal anastomosis and Subtotal colectomy with cecal-rectal anastomosis in Slow Transit Constipation and Surgery, sponsored by Third Military Medical University. Active, not recruiting at 14 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients (≥18 years of age) of either sex
  2. Patients with conditions in agreement with the Roman IV criteria of functional constipation
  3. Patients have less than one complete spontaneous bowel movement per week
  4. Patients rely on laxatives to assist defecation for a long time
  5. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
  6. Patients were refractory to conservative treatment for more than 1 year
  7. Patients with a strong desire for surgery

Exclusion criteria

Exclusion criteria

  1. Pregnant or breast-feeding women
  2. Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
  3. Patients with colorectal neoplasms
  4. Patients with small intestinal slow transit
  5. Patients with constipation-predominant irritable bowel syndrome
  6. Patients with inflammatory bowel disease
  7. Patients with ileostomy
  8. Patients with severe psychiatric disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (actual)

Study arms

  • Active comparator
    Total colectomy with ileorectal anastomosis

    Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation.

    Procedure: Total colectomy with ileorectal anastomosis

  • Experimental
    Subtotal colectomy with cecal-rectal anastomosis

    Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation.

    Procedure: Subtotal colectomy with cecal-rectal anastomosis

Interventions

  • ProcedureTotal colectomy with ileorectal anastomosis

    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.

  • ProcedureSubtotal colectomy with cecal-rectal anastomosis

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: From the pre-operation to 36 months following surgery

Secondary outcomes

  1. 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).

    Time frame: From the pre-operation to 36 months following surgery

  2. 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).

    Time frame: From the pre-operation to 36 months following surgery

  3. 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.

    Time frame: From the pre-operation to 36 months following surgery

  4. The number of bowel movements per week

    The number of bowel movements will be recorded in terms of times per week.

    Time frame: From the pre-operation to 36 months following surgery

  5. 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).

    Time frame: From the pre-operation to 36 months following surgery

  6. The incidence of abdominal pain

    The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.

    Time frame: From the pre-operation to 36 months following surgery

  7. The incidence of bloating

    The incidence of bloating will be recorded in terms of percent

    Time frame: From the pre-operation to 36 months following surgery

  8. The incidence of diarrhea

    The incidence of diarrhea will be recorded in terms of percent.

    Time frame: From the pre-operation to 36 months following surgery

  9. The incidence of straining

    The incidence of straining will be recorded in terms of percent.

    Time frame: From the pre-operation to 36 months following surgery

  10. The incidence of laxative use

    The incidence of laxative use will be recorded in terms of percent.

    Time frame: From the pre-operation to 36 months following surgery

  11. The incidence of enema use

    The incidence of enema use use will be recorded in terms of percent.

    Time frame: From the pre-operation to 36 months following surgery

  12. Intraoperative measures

    Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.

    Time frame: Perioperative period

07

Study locations

14 sites
  • Army Medical Center (Daping Hospital)
    Yuzhong, Chongqing Municipality 400042, China
  • No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
    Lanzhou, Gansu 730050, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430062, China
  • General Hospital of the Eastern Theater Cammand of the PLA
    Nanjing, Jiangsu 210002, China
  • The First Hospital of China Medical University
    Shengyang, Liaoning 110001, China
  • Qingdao Municipal Hospital
    Qingdao, Shandong 266011, China
  • Renji Hospital, Shanghai Jiaotong University
    Pudong, Shanghai Municipality 200127, China
  • Shanghai Pudong New Area People's Hospital
    Pudong, Shanghai Municipality 201299, China
  • Xijing Hospital
    Xi’an, Shanxi 710032, China
  • Chengdu Analrectal Hospital
    Chengdu, Sichuan 610017, China
  • The General Hospital of Western Theater Command
    Chengdu, Sichuan 610036, China
  • The Second People's Hospital of Yibin
    Yibin, Sichuan 644000, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310014, China
08

References and documents

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 30948148 ↗
  • Wei 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 25887580 ↗
  • Perivoliotis 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 35020001 ↗
  • Knowles 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 28960922 ↗
  • Deng 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 36914915 ↗
  • Tian 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05352074
Lead sponsor
Third Military Medical University
Responsible party
Weidong Tong (Director, Third Military Medical University) — Principal investigator
First posted
Apr 28, 2022
Start date
Mar 27, 2022
Primary completion
May 1, 2025
Completion
May 1, 2028 (estimated)
Last update
Apr 14, 2026

Study contacts

Weidong Tong, MD
study director · Army Medical Center (Daping Hospital)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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