Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer

NCT05671809 | Not Yet Recruiting

• 1 other identifier: 2022-097
• Study Type: observational
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatments for patients with locally advanced rectal cancer. These sphincter-saving operations may be accompanied by a series of functional disorders. Prospective studies dynamically evaluating the different roles of surgery and NCRT on anorectal function are lacking. Methods/design The study is a prospective, observational, controlled, multicentre study. After screening for eligibility and obtaining informed consent, a total of 402 rectal cancer patients aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University are included in the trial. The primary outcome measure is the average resting pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years. Discussion We expect the program to provide more information on therapeutical options and strategies to reduce anorectal dysfunction of rectal cancer patients who have been undergone sphincter preservation treatments.

Conditions

Rectal Cancer

Keywords

Anorectal function, Rectal cancer, NCRT, Surgery

Outcome Measures

Primary Outcomes (1)

• ARP

  The average resting pressure (ARP) of anal sphincter

  Baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), follow-up visits (every 3 to 6 months, T4, T5……)

Secondary Outcomes (1)

• MASCP and Wexner

  Baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), follow-up visits (every 3 to 6 months, T4, T5……)

Study Arms (3)

NCRT with surgery

Rectal cancer patients who will undergo sphincter-preserving therapy, that is NCRT with surgery.

Other: NCRT with surgery, or NCT with surgery, or surgery

NCT with surgery

Rectal cancer patients who will undergo sphincter-preserving therapy, that is NCT with surgery.

Other: NCRT with surgery, or NCT with surgery, or surgery

surgery

Rectal cancer patients who will undergo sphincter-preserving therapy, that is surgery.

Other: NCRT with surgery, or NCT with surgery, or surgery

Interventions

NCRT with surgery, or NCT with surgery, or surgery OTHER

The eligible patients who voluntarily sign the consent form will undergo either NCRT with surgery, or NCT with surgery, or surgery according to treatment guidelines.

NCRT with surgery; NCT with surgery; surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with rectal cancer at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University will be assessed for suitability for inclusion.

You may qualify if:

• years of age. Rectal cancer with pathological diagnosis. Patient will undergo sphincter-preserving therapies. ECOG score for performance status is 0-2. Written informed consent.

You may not qualify if:

• Patients who have undergone rectal cancer surgery. Patients who have received pelvic radiotherapy. Patients with other active malignant tumors. Recently (less than 4 weeks) received surgery or patients with recent severe trauma.
• Significant cardiac disease: congestive heart failure of New York Heart Association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction).
• Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis.
• Patients with toxicity (CTCAE Grade ≥ 2) caused by previous treatment that has not subsided.
• Pregnant or lactating women.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Nanfang Hospital, Southern Medical University: collaborator

Related Publications (20)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Newland RC, Chapuis PH, Dent OF, Bokey EL. Total mesorectal excision is optimal surgery for rectal cancer: a Scandinavian consensus. Br J Surg. 1996 Mar;83(3):427-8. doi: 10.1002/bjs.1800830355. No abstract available.

  PMID: 8665225 BACKGROUND

• Keller DS, Berho M, Perez RO, Wexner SD, Chand M. The multidisciplinary management of rectal cancer. Nat Rev Gastroenterol Hepatol. 2020 Jul;17(7):414-429. doi: 10.1038/s41575-020-0275-y. Epub 2020 Mar 12.

  PMID: 32203400 BACKGROUND

• Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

  PMID: 15496622 BACKGROUND

• Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rodel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

  PMID: 22529255 BACKGROUND

• Sipaviciute A, Sileika E, Burneckis A, Dulskas A. Late gastrointestinal toxicity after radiotherapy for rectal cancer: a systematic review. Int J Colorectal Dis. 2020 Jun;35(6):977-983. doi: 10.1007/s00384-020-03595-x. Epub 2020 Apr 16.

  PMID: 32296933 BACKGROUND

• Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X.

  PMID: 22935240 BACKGROUND

• Celerier B, Denost Q, Van Geluwe B, Pontallier A, Rullier E. The risk of definitive stoma formation at 10 years after low and ultralow anterior resection for rectal cancer. Colorectal Dis. 2016 Jan;18(1):59-66. doi: 10.1111/codi.13124.

  PMID: 26391723 BACKGROUND

• De Nardi P, Testoni SG, Corsetti M, Andreoletti H, Giollo P, Passaretti S, Testoni PA. Manometric evaluation of anorectal function in patients treated with neoadjuvant chemoradiotherapy and total mesorectal excision for rectal cancer. Dig Liver Dis. 2017 Jan;49(1):91-97. doi: 10.1016/j.dld.2016.09.005. Epub 2016 Sep 22.

  PMID: 27720700 BACKGROUND

• Sun W, Dou R, Chen J, Lai S, Zhang C, Ruan L, Kang L, Deng Y, Lan P, Wang L, Wang J. Impact of Long-Course Neoadjuvant Radiation on Postoperative Low Anterior Resection Syndrome and Quality of Life in Rectal Cancer: Post Hoc Analysis of a Randomized Controlled Trial. Ann Surg Oncol. 2019 Mar;26(3):746-755. doi: 10.1245/s10434-018-07096-8. Epub 2018 Dec 7.

  PMID: 30536129 BACKGROUND

• Bharucha AE. Update of tests of colon and rectal structure and function. J Clin Gastroenterol. 2006 Feb;40(2):96-103. doi: 10.1097/01.mcg.0000196190.42296.a9.

  PMID: 16394868 BACKGROUND

• Kitaguchi D, Nishizawa Y, Sasaki T, Tsukada Y, Ito M. Clinical benefit of high resolution anorectal manometry for the evaluation of anal function after intersphincteric resection. Colorectal Dis. 2019 Mar;21(3):335-341. doi: 10.1111/codi.14528. Epub 2018 Dec 31.

  PMID: 30537066 BACKGROUND

• Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

  PMID: 8416784 BACKGROUND

• Chen SC, Futaba K, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Functional anorectal studies in patients with low anterior resection syndrome. Neurogastroenterol Motil. 2022 Mar;34(3):e14208. doi: 10.1111/nmo.14208. Epub 2021 Jun 18.

  PMID: 34145694 BACKGROUND

• Birnbaum EH, Dreznik Z, Myerson RJ, Lacey DL, Fry RD, Kodner IJ, Fleshman JW. Early effect of external beam radiation therapy on the anal sphincter: a study using anal manometry and transrectal ultrasound. Dis Colon Rectum. 1992 Aug;35(8):757-61. doi: 10.1007/BF02050325.

  PMID: 1643999 BACKGROUND

• Lim JF, Tjandra JJ, Hiscock R, Chao MW, Gibbs P. Preoperative chemoradiation for rectal cancer causes prolonged pudendal nerve terminal motor latency. Dis Colon Rectum. 2006 Jan;49(1):12-9. doi: 10.1007/s10350-005-0221-7.

  PMID: 16292664 BACKGROUND

• Bjoern MX, Perdawood SK. Manometric assessment of anorectal function after transanal total mesorectal excision. Tech Coloproctol. 2020 Mar;24(3):231-236. doi: 10.1007/s10151-020-02147-3. Epub 2020 Feb 1.

  PMID: 32008213 BACKGROUND

• Fratta CL, Pinheiro LV, Costa FO, Magro DO, Martinez CAR, Coy CSR. STUDY OF ANORECTAL PHYSIOLOGY PRE AND POS NEOADJUVANT THERAPY FOR RECTAL CANCER BY ANORECTAL MANOMETRY AND JORGE-WEXNER SCORE. Arq Gastroenterol. 2022 Jul-Sep;59(3):334-339. doi: 10.1590/S0004-2803.202203000-61.

  PMID: 36102428 BACKGROUND

• Ammann K, Kirchmayr W, Klaus A, Muhlmann G, Kafka R, Oberwalder M, De Vries A, Ofner D, Weiss H. Impact of neoadjuvant chemoradiation on anal sphincter function in patients with carcinoma of the midrectum and low rectum. Arch Surg. 2003 Mar;138(3):257-61. doi: 10.1001/archsurg.138.3.257.

  PMID: 12611569 BACKGROUND

• Shi J, Cheng YK, He F, Zheng J, Wang YL, Wan XB, Lin HC, Fan XJ. Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study. BMC Cancer. 2023 May 22;23(1):467. doi: 10.1186/s12885-023-10951-x.

  PMID: 37217903 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Xin-juan Fan, Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Xiang-Bo Wan, Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Hong-Cheng Lin, Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Shi

CONTACT

+862085655907; shij36@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share