Clinical trial NCT05421702: Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt
Official title: Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer Stage I
Colon Cancer Stage II
Keywords: Colon cancer
Colectomy
Mesocolic
Conventional
Laparoscopic
Surgical
Pathological
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Operable colon cancer cases
Primary purpose: TREATMENT

Brief summary: The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt

Detailed description: Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .

When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).

The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.

CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.

Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.

Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.

The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?

Eligibility criteria: Inclusion Criteria:

1. Both sexes will be included.
2. Age: all adult patients.
3. All diagnosed patients with operable cancer colon.
4. Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
5. Fit patients.

Exclusion Criteria:

1. Irresectable colon cancer.
2. Inoperable colon cancer.
3. Rectal cancer.
4. Unfit patients.

Primary outcomes:
measure: Postoperative lymph node status
timeFrame: 2 weeks postoperative
measure: Postoperative histopathological result
timeFrame: 2 weeks postoperative
measure: Occurence of anastomotic leak
timeFrame: within 4 weeks postoperative
measure: Amount of anastomotic leak
timeFrame: within 4 weeks postoperative
measure: Intraoperative visceral injury type
timeFrame: Intraoperative reporting
measure: Intraoperative visceral injury management
timeFrame: Intraoperative reporting
measure: Postoperative complications
timeFrame: 4 weeks postoperative
measure: Operative time
timeFrame: Reporting immediately postoperative (at end of operation)
measure: Intraoperative vascular injury
timeFrame: Intraoperative
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Resection margins in postoperative histopathological status
timeFrame: 2 weeks postoperative
measure: Postoperative peritonitis
timeFrame: 4 weeks postoperative
measure: Colon cancer stage
timeFrame: 2 weeks Preoperative
measure: Postoperative faecal fistula
timeFrame: 12 weeks postoperative
measure: length of resected mesocolon
timeFrame: 2 weeks postoperative
measure: Urological complications
timeFrame: Intraoperative and 4 weeks postoperative
measure: Carcinoembryonic antigen (CEA) level
timeFrame: 2 weeks preoperative
measure: Type of anastomosis
timeFrame: Intraoperative
Secondary outcomes:
measure: Age
timeFrame: preoperative
measure: Preoperative haemoglobin level
timeFrame: preoperative
measure: Type of colonic anastomosis
timeFrame: Intraoperative
measure: Preoperative histopathological result
timeFrame: 2 weeks preoperative
measure: Neoadjuvant therapy
timeFrame: 2 weeks Preoperative
measure: Site of cancer colon
timeFrame: 2 weeks preoperative
measure: Neurological complications
timeFrame: 4 weeks postoperative
measure: Preoperative preparation
timeFrame: 3 days Preoperative
measure: Cardiopulmonary complications
timeFrame: 4 weeks postoperative
measure: Conversion to open surgery
timeFrame: intraoperative
measure: application of subcutaneous suction
timeFrame: 1 week Postoperative
measure: Average daily amount in subcutaneous suction
timeFrame: 2 weeks Postoperative
measure: Average daily amount in intraperitoneal drain
timeFrame: 2 weeks Postoperative
measure: Wound infection
timeFrame: 2 weeks postoperative
measure: Postoperative ileus
timeFrame: 2 weeks postoperative
measure: Hospital stay
timeFrame: 4 weeks postoperative
measure: Wound dehiscence
timeFrame: 4 weeks postoperative
measure: Preoperative colonoscopic examination result
timeFrame: 2 weeks preoperative
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag University
name: Ahmed E Ahmed, Professor
role: STUDY_CHAIR
affiliation: Sohag University
name: Mena Z Helmy, Ass prof.
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Mostafa F Mohammed, Ass lecturer
role: PRINCIPAL_INVESTIGATOR
References: