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Anastomotic StenosisNCT06036862

Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis

A study testing Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction in people with Anastomotic Stenosis, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be accompanied by frequent defecation, which affects the quality of life, and patients face the outcome of permanent stoma or temporary stoma again. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anastomotic Stenosis
What is being tested?
Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Aug 2023to 31 Dec 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 18-70 years old;
  • ECOG performance status score 0-2;
  • previous rectal resection;
  • patients diagnosed with middle and low rectal anastomotic tubular stenosis;
  • can tolerate general anesthesia;
  • The subjects and their family members, who could understand the study protocol and were willing to participate, signed the informed consent form.

Who cannot join

  • patients with acute intestinal obstruction, intestinal perforation or intestinal bleeding requiring emergency surgery;
  • severe pelvic adhesion and frozen pelvis;
  • patients with unstable primary tumors or combined with tumors at other sites;
  • previous history of left hemicolectomy;
  • ASA grade IV to V;
  • combined organ resection;
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  • severe mental illness;
  • pregnant or lactating women;
  • severe cardiovascular disease, uncontrolled infection or other uncontrolled comorbidities;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liang Huang, Doctor contact

15989101216

huangl75@mail.sysu.edu.cn

China1 site, 1 recruiting
  • Sixth Affiliated Hospital of Sun yat-sen University

    Guangzhou, Guangdong

    Liang Huang, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis

Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be accompanied by frequent defecation, which affects the quality of life, and patients face the outcome of permanent stoma or temporary stoma again. Traditional transabdominal resection and reconstruction of rectal anastomotic stenosis is more likely to occur due to unclear anatomical structure, dense scars around the intestinal canal, complications such as ureteral and urethral injury and massive presacral hemorrhage. In addition,41%of patients with anastomotic stenosis who underwent reoperation through abdominal surgery had anastomotic leakage again, and up to 30% of patients could not close the stoma. The advantages of transanal total mesorectal excision (taTME) using a transanal approach for total mesorectal excision in the treatment of middle and low rectal cancer with difficult pelvis have been demonstrated by our group. However, taTME has rarely been explored in the treatment of anastomotic stenosis. Our team retrospectively summarized the patients who underwent transabdominal transanal endoscopic resection and reconstruction of anastomotic stenosis (l-taTME), and initially demonstrated the safety and effectiveness of this surgical method, with a stoma closure rate of 90%. Although the advantages of l-taTME in the treatment of severe rectal anastomotic stenosis are obvious in theory and preliminary clinical practice, there is a lack of prospective studies. Therefore, the investigators plan to conduct a prospective clinical study to observe the safety and efficacy of l-taTME reconstruction surgery, and to provide high-level evidence-based medical basis for the selection of resection and reconstruction surgery for patients with rectal anastomotic stenosis.

Read the detailed description

Colorectal cancer is the most common malignant tumor of the digestive tract. At present, surgery is still the main treatment for rectal cancer. Although stapler anastomosis improves the safety of surgical resection and reconstruction for middle and low rectal cancer, surgical complications, especially anastomotic leakage, are inevitable, especially for middle and low rectal cancer, where the incidence of anastomotic leakage reaches 8-11%. The outcome of anastomotic leakage will lead to anastomotic stenosis, especially in middle and low rectal cancer after neoadjuvant radiotherapy, and the incidence of anastomotic stenosis is as high as 3%-10%. Previous studies have suggested that anastomotic diameter < 20mm is considered as an anastomotic stenosis, and it has also been shown that an anastomotic diameter less than 1/3 of the original diameter of the intestinal lumen is considered as an anastomotic stenosis. Anastomotic stenosis can not only cause intestinal obstruction symptoms, such as abdominal distension and abdominal pain, but also be accompanied by frequent defecation, which affects the quality of life, and many patients face the outcome of permanent stoma or temporary stoma again.

Anastomotic stenosis is divided into membranous stenosis and tubular stenosis according to the degree of stenosis. For anastomotic membranous stenosis, endoscopic incision of the stenosis ring or balloon dilatation is the preferred method for the treatment of membranous stenosis. However, endoscopic scar incision and balloon dilation require repeated, multiple treatments to achieve long-term effectiveness, with the risk of perforation, pelvic infection, and bleeding. Balloon dilatation or scar incision has little effect on patients with low anastomosis position or tubular stenosis, and nearly 30% of patients need to undergo resection and reconstruction of the stenotic anastomosis. As anastomotic stenosis is often caused by anastomotic leakage, anastomotic ischemia, radiotherapy and chemotherapy, use of stapler, pelvic infection and low anastomosis, the anatomical structure is unclear, the scar around the bowel is dense, and complications such as ureteral and urethral injury and massive bleeding of presacral veins are more likely to occur during the resection and reconstruction of the stricture. Lefevre et al. reported 33 patients who underwent resection and reconstruction of transabdominal rectal anastomotic stenosis, and the incidence of perioperative complications was 54.5%, including anastomotic leakage of 18%(6/33) and postoperative intestinal obstruction of 12%. Genser et al. reported 50 patients with surgical treatment of anastomotic stenosis, of whom 12(24%) received intraoperative blood transfusion, with an average blood transfusion volume of 2.5 units. The incidence of intraoperative complications was 12%, including 5 cases of bladder injury and 1 case of splenectomy due to splenic injury due to unclear anatomical location. Westerduin et al. summarized 59 patients who underwent secondary surgery for anastomotic leakage and stenosis, and 41% of them had recurrent anastomotic leakage 14 months after surgery. During the follow-up of 27 months, only 66% of the patients regained intestinal continuity,24%of the patients received permanent colostomy, and 10% of the patients retained ileostomy.

Due to the difficulty of surgery, it is difficult to remove the scar tissue around the anastomosis in the traditional abdominal resection and reconstruction surgery. The new rectorectum cannot be pulled out and anastomosed with the distal rectoanal canal again. After reluctant anastomosis, the incidence of anastomotic leakage is still high due to the high tension of rectorectum, and many patients have to accept permanent stoma. Transanal total mesorectal excision (taTME), which uses a transanal approach to perform total mesorectal excision, has been demonstrated by our team for the surgical treatment of middle and low rectal cancer with difficult pelvis. However, the use of taTME in the treatment of anastomotic stenosis is rarely explored at present. Our team first reported this surgical method in 2021. The investigators retrospectively summarized 17 patients who underwent resection and reconstruction of anastomotic stenosis by transabdominal transanal endoscopic surgery. The ileostomy or colostomy was closed in 15 patients, which proved the safety and effectiveness of this surgical method. Transabdominal transanal endoscopic resection and reconstruction surgery has obvious advantages in the treatment of patients with rectal anastomotic stenosis. First, it can accurately separate the narrow distal intestine, and transanal anastomosis of the substitute rectum and the distal rectoanal canal can be performed, which reduces the difficulty of reconstruction. Secondly, from the distal normal anorectal canal, it can enter the normal anatomical structure space, and the narrow scar segment can be completely resected by endoscopic magnification. At the same time, it can reduce the accidental injury of the surrounding normal tissue and significantly reduce the incidence of intraoperative complications. Finally, the mobilization of the left hemicolon and splenic flexure of the abdomen was completed laparoscopically, and the specimen was removed through the anus, which did not require additional abdominal incision and thus reduced trauma. Although the advantages of transanal transabdominal combined with laparoscopic resection and reconstruction in the treatment of severe rectal anastomotic stenosis are very obvious in theory and preliminary clinical practice, there is a lack of prospective studies.

For the above reasons, the investigators plan to conduct a prospective clinical study to observe the safety and efficacy of transanal laparoscopic resection and reconstruction in patients with rectal anastomotic stenosis, in order to improve the quality of life of patients with rectal anastomotic stenosis, and to provide high-level evidence-based medical basis for the selection of resection and reconstruction surgery for patients with rectal anastomotic stenosis.

Being tested
Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstructionProcedure or surgery

    Laparoscopic or open surgery was selected according to the patient's condition, surgical history and surgeon's experience.According to the extent of the rectal stenosis, the proximal colon was dissected.A circular incision was made above the dentate line and the broken end was sutured. After the intestinal cavity was closed, a single port was inserted through the anus, and a transanal endoscopic platform was established after pneumoperitoneum infusion.The stenotic and scar segments were removed free upward.Through the pelvic cavity and into the abdominal cavity from the bottom up. The narrow rectum and proximal colon were pulled out of the anus through the anus, and the diseased bowel was removed. According to the distance of the remaining distal rectum, stapler or manual anastomosis or Bacon operation was selected.

Study groups in NCT06036862
Study groupRoleWhat they receive
Patients with severe rectal anastomotic stenosisExperimentalFocusing on Patients with severe rectal anastomotic stenosis, espically long length and ultra lower firbrotic stenosis
Receives: Procedure: Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stoma recovery rate

    whether the stoma recovery and restoration of bowel continuation

    Measured: 3 months after surgery

Secondary outcomes (19)
  1. incidence of postoperative anastomotic leakage

    whether the occurence of anastomotic leakage

    Measured: 1 month after surgery

  2. incidence of postoperative anastomotic bleeding

    whether the occurence of anastomotic bleeding

    Measured: Duration of 7 days after surgery

  3. Incidence of severe bowel dysfunction

    Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)

    Measured: 3 months after stoma recovery

  4. Incidence of severe bowel dysfunction

    Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)

    Measured: 6 months after stoma recovery

  5. Incidence of severe bowel dysfunction

    Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)

    Measured: 1 year after stoma recovery

  6. Incidence of severe bowel dysfunction

    Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)

    Measured: 2 years after stoma recovery

  7. Anorectal function

    Anorectal pressure Rectal sensory function Rectoanal reflex function

    Measured: 1 year after stoma recovery

  8. Anorectal function

    Anorectal pressure Rectal sensory function Rectoanal reflex function

    Measured: 2 year after stoma recovery

  9. bowel function

    Memorial Sloan-Kettering Cancer Center bowel function instrument

    Measured: 3 months after stoma recovery

  10. bowel function

    Memorial Sloan-Kettering Cancer Center bowel function instrument

    Measured: 6 months after stoma recovery

  11. bowel function

    Memorial Sloan-Kettering Cancer Center bowel function instrument

    Measured: 1 year after stoma recovery

  12. bowel function

    Memorial Sloan-Kettering Cancer Center bowel function instrument

    Measured: 2 year after stoma recovery

  13. Quality of life evaluation after stoma closure

    European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)

    Measured: 3 months

  14. Quality of life evaluation after stoma closure

    European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)

    Measured: 6 months

  15. Quality of life evaluation after stoma closure

    European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)

    Measured: 1 year

  16. Quality of life evaluation after stoma closure

    European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)

    Measured: 2 years

  17. Quality of life evaluation after stoma closure

    European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)

    Measured: 3 years

  18. Inraoperative condition

    operation time and whether to convert to laparotomy

    Measured: In the process of operation

  19. Perioperative recovery time

    Duration of analgesics in hours For the first time the exhaust time in hours Time to first defecation in hours Time to first fluid intake in hours Time to resume normal diet in hours Abdominal drainage tube removal time in days Catheter removal time in days Length of postoperative hospital stay in days

    Measured: perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036862
Sponsor's protocol ID
GIHSYSU-TLCAS
Status last verified
Sep 2023
First submitted
10 Aug 2023
Last updated
14 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.

    PubMed 24225001
  • Lu P, Fields AC, Vise AS, Shabat G, Irani JL, Bleday R, Goldberg JE, Melnitchouk N. Anatomic Distribution of Colorectal Adenocarcinoma in Young Patients. Dis Colon Rectum. 2019 Aug;62(8):920-924. doi: 10.1097/DCR.0000000000001422.

    PubMed 31162374
  • Moran BJ. Stapling instruments for intestinal anastomosis in colorectal surgery. Br J Surg. 1996 Jul;83(7):902-9. doi: 10.1002/bjs.1800830707.

    PubMed 8813772
  • Braunschmid T, Hartig N, Baumann L, Dauser B, Herbst F. Influence of multiple stapler firings used for rectal division on colorectal anastomotic leak rate. Surg Endosc. 2017 Dec;31(12):5318-5326. doi: 10.1007/s00464-017-5611-0. Epub 2017 Jun 20.

    PubMed 28634627
  • Lee SY, Kim CH, Kim YJ, Kim HR. Anastomotic stricture after ultralow anterior resection or intersphincteric resection for very low-lying rectal cancer. Surg Endosc. 2018 Feb;32(2):660-666. doi: 10.1007/s00464-017-5718-3. Epub 2017 Jul 19.

    PubMed 28726144
  • Fegiz G, Angelini L, Bezzi M. Rectal cancer: restorative surgery with the EEA stapling device. Int Surg. 1983 Jan-Mar;68(1):13-8.

    PubMed 6853077
  • Hughes DL, Cornish J, Morris C; LARRIS Trial Management Group. Functional outcome following rectal surgery-predisposing factors for low anterior resection syndrome. Int J Colorectal Dis. 2017 May;32(5):691-697. doi: 10.1007/s00384-017-2765-0. Epub 2017 Jan 27.

    PubMed 28130593
  • Bruns ERJ, Borstlap WA, van Duijvendijk P, van der Zaag-Loonen HJ, Buskens CJ, van Munster BC, Bemelman WA, Tanis PJ. The Association of Preoperative Anemia and the Postoperative Course and Oncological Outcome in Patients Undergoing Rectal Cancer Surgery: A Multicenter Snapshot Study. Dis Colon Rectum. 2019 Jul;62(7):823-831. doi: 10.1097/DCR.0000000000001360.

    PubMed 31188183
  • Garcea G, Sutton CD, Lloyd TD, Jameson J, Scott A, Kelly MJ. Management of benign rectal strictures: a review of present therapeutic procedures. Dis Colon Rectum. 2003 Nov;46(11):1451-60. doi: 10.1007/s10350-004-6792-x.

    PubMed 14605561
  • Artifon EL, Castano Llano R, Otoch JP, Tchekmedyian AJ. [Endoscopic dilation of the gastrointestinal tract]. Rev Gastroenterol Peru. 2015 Jan;35(1):45-61. Spanish.

    PubMed 25875518
  • Nguyen-Tang T, Huber O, Gervaz P, Dumonceau JM. Long-term quality of life after endoscopic dilation of strictured colorectal or colocolonic anastomoses. Surg Endosc. 2008 Jul;22(7):1660-6. doi: 10.1007/s00464-007-9679-9. Epub 2007 Dec 11.

    PubMed 18074183
  • Suchan KL, Muldner A, Manegold BC. Endoscopic treatment of postoperative colorectal anastomotic strictures. Surg Endosc. 2003 Jul;17(7):1110-3. doi: 10.1007/s00464-002-8926-3. Epub 2003 May 6.

    PubMed 12728381
  • Kawada K, Sakai Y. Preoperative, intraoperative and postoperative risk factors for anastomotic leakage after laparoscopic low anterior resection with double stapling technique anastomosis. World J Gastroenterol. 2016 Jul 7;22(25):5718-27. doi: 10.3748/wjg.v22.i25.5718.

    PubMed 27433085
  • Vignali A, Fazio VW, Lavery IC, Milsom JW, Church JM, Hull TL, Strong SA, Oakley JR. Factors associated with the occurrence of leaks in stapled rectal anastomoses: a review of 1,014 patients. J Am Coll Surg. 1997 Aug;185(2):105-13. doi: 10.1016/s1072-7515(97)00018-5.

    PubMed 9249076
  • Lefevre JH, Bretagnol F, Maggiori L, Ferron M, Alves A, Panis Y. Redo surgery for failed colorectal or coloanal anastomosis: a valuable surgical challenge. Surgery. 2011 Jan;149(1):65-71. doi: 10.1016/j.surg.2010.03.017. Epub 2010 May 7.

    PubMed 20451231

Questions about this trial

What is this clinical trial studying?

A study testing Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction in people with Anastomotic Stenosis, run by Sun Yat-sen University at 1 site 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 6 inclusion and 9 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 14 Sep 2023. 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 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?

Contact Liang Huang, Doctor (15989101216, huangl75@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stoma recovery rate (time frame: 3 months after 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 NCT06036862, which also lists 21 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 Sep 2023.

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