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NCT Number: NCT02649647

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery.

Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis.

It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Qiyuan Qin, M.D.

CONTACT

[email protected]

86-20-38254052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-75 years old
  • ECOG performance status: 0-2
  • Histologically confirmed adenocarcinoma of the rectum
  • Distal border of the tumor located ≤ 12 cm from the anal verge
  • Primary stage T3-4 or any node-positive disease
  • Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy
  • Conventional fractionated radiotherapy of at least 45 Gy
  • Resectable disease after neoadjuvant chemoradiotherapy
  • No evidence of distant metastasis
  • Amenable to sphincter-preserving surgery
  • Tolerable to general anesthesia
  • Provision of written informed consent

Exclusion criteria

  • Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
  • Synchronous colon cancer
  • History of colorectal resection except appendectomy
  • Acute intestinal obstruction or perforation
  • Multiple visceral resection
  • Abdominoperineal resection
  • American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
  • Pregnant or nursing, fertile patients do not use effective contraception
  • Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
  • Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Treatment and study plan

Conventional resection

Procedure

The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Proximally extended resection

Procedure

The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Primary outcomes

  1. Incidence of major bowel dysfunction

    Time frame: at the time of 12 months after the restoration of defunctioning stoma

    Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.

Secondary outcomes

  1. Incidence of anastomotic leakage

    Time frame: up to 6 months postoperatively

  2. Incidence of anastomotic stenosis

    Time frame: 12 months postoperatively

  3. Incidence of major bowel dysfunction

    Time frame: at the time of 36 months after the restoration of defunctioning stoma

    Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.

  4. Incidence of major bowel dysfunction

    Time frame: at the time of 60 months after the restoration of defunctioning stoma

    Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.

  5. 3-year disease free survival

    Time frame: 3 years

  6. 5-year overall survival

    Time frame: 5 years

  7. Incidence of anastomotic haemorrhage

    Time frame: up to 1 month postoperatively

  8. Incidence of intraoperative complication

    Time frame: at the time of surgery

  9. Postoperative morbidity

    Time frame: up to 30 days postoperatively

  10. Postoperative mortality

    Time frame: up to 30 days postoperatively

  11. Quality of life impairment

    Time frame: at the time of 12 months after the restoration of defunctioning stoma

    Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.

  12. Quality of life impairment

    Time frame: at the time of 36 months after the restoration of defunctioning stoma

    Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.

  13. Quality of life impairment

    Time frame: at the time of 60 months after the restoration of defunctioning stoma

    Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.

Other outcomes

  1. Incidence of major bowel dysfunction in patients with tumor of different location

    Time frame: at the time of 12 months after the restoration of defunctioning stoma

  2. Incidence of major bowel dysfunction in patients with tumor of different location

    Time frame: at the time of 36 months after the restoration of defunctioning stoma

  3. Incidence of major bowel dysfunction in patients with tumor of different location

    Time frame: at the time of 60 months after the restoration of defunctioning stoma

  4. Incidence of anastomotic complication in patients with tumor of different location

    Time frame: up to 12 months postoperatively

  5. Operative duration by minutes

    Time frame: at the time of surgery

  6. Intraoperative blood loss by millilitres

    Time frame: at the time of surgery

  7. Postoperative rehabilitation time

    Time frame: up to 1 months postoperatively

  8. Postoperative hospital stay by days

    Time frame: up to 1 months postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Qiyuan Qin, M.D.

CONTACT

[email protected]

86-20-38254052

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Collaborators

  • Peking Union Medical College Hospital
  • Shanghai Changzheng Hospital

Registry information

Official study title

Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Acronym: PERN

Important dates

Study start
2016
Primary completion
2024
Study completion
2028
First posted
Jan 7, 2016
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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