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Cola

Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion

Procedure: The endoscopy explore right colon with frontal view and frontal view

The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization

Proximal retroflexion

The investigator explore twice right colon with frontal viewing

Frontal view

Mª Henar Núñez Rodriguez

Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial

Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool

Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate

To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion

Hospital del Río Hortega

Principal Investigator: Dra Mª Henar Núñez Rodriguez

Colonic Neoplasms

participants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure

participants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure

resection of right colon cancer by this radical approach

combined medial and caudal approach right hemicolectomy open and laparoscopic

Reham Z Mohamed, master

Ali H Elshewy, PhD

Abdelrahman A Sarhan, PhD

Gamal M Osman, PhD

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.

The incidence of colorectal cancer is increasing. Slight shift towards right colon cancer is noticed in the last 2 decades in Egypt. This can be attributed to advances in diagnostic tools and increased public health awareness as right sided colon cancer was almost presented late as most of tumors located in the capacious cecum. Hence, early diagnosis with good radical procedure offers better outcome, quality of life and survival. Many approaches for right colon resection were described. In this study we adopted the combined medial and caudal approach for right colon resection in cases of right colon cancer in both open and laparoscopic techniques.

Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.

As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.

This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:

Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants

All patients with inclusion criteria were subjected to preoperative assessment in the form of:

* Full history.
* Clinical evaluation.
* Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour marker CEA).
* Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
* Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
* Determined whether participants underwent open or laparoscopic operation is multifactorial e.g., patients desire, contraindications for laparoscopy and mass size if more than 5 cm preferred to have open surgery.
* Informed written consent taken from the patients or the legal guardian.

operative technique: both groups offered combined medial and caudal approach

* Fasting for 6 hours with no oral intake or only clear fluids intake the day before or better bowel preparation.
* After confirming the availability of blood of matching blood group, general anesthesia is inducted and prophylactic antibiotics are given.
* Patient positioning:

  1. group I: (Open cases) The standard position for an open right hemicolectomy is supine with strapping of the ankle and wrists, such as the Trendelenburg position. The surgeon stands on the patient's left, and the first assistant stands across from the surgeon on the patient's right. The scrub nurse stands beside the surgeon. If a second assistant is needed, he or she usually stands across from the surgeon to the left of the first assistant.
  2. group II: laparoscopic cases: The patient should be placed in the supine position with his two legs apart and arms tucked beside the body.

The surgeon should stand between the patient's legs with the assistant standing on the patient's left and the camera operator standing on the assistant's left side, and the scrub nurse on the patient's right side.

The video monitor is placed on the patient's upper right.

* Abdominal access and trocar placement by open or closed technique using veress needle for pneumoperitoneum with an intraperitoneal pressure of 14 mmHg.
* The procedure requires 5 trocars.
* A 10 mm trocar is placed 3 cm below umbilicus for the 30° angled telescope to get an adequate view. The incision would be enlarged to extract the specimen and performing anastomosis.
* A12 mm trocar is introduced 5 cm below the telescope port for the surgeon right hand instrument.
* A 5 mm port is inserted at the McBurney's point for the surgeon's left hand instrument.
* Additional two 5 mm trocars are placed at the opposite of McBurney's point and the right subcostal position respectively for the assistant to retract and display the colon and mesocolon.

Intraoperatively, all patients will be assessed for:

* Time of the procedure.
* Amount of blood loss.

post operatively: Postoperative medications given. Monitoring of vital signs and drains. post operative assesment of pain is subjective to the participant as he gave it a score from 1 to 10. minimal pain score(1 to 3), mild (4 to 6) and sever (7 to 10). Ambulation and clear oral fluids started when intestinal sounds are audible followed by soft diet. The intraperitoneal tube drain removed when there is less than 50cc of fluid per 24h or after performing ultrasonography.

Follow up:

Participants are reviewed as outpatients weekly for 1 month or more frequent if they develop any complications between their visits.

The postoperative pathological results, number of lymph node dissection, postoperative exhaust time, postoperative abdominal drain volume and duration, postoperative short term complications, hospital stay and postoperative pathological staging will be recorded.

all participants underwent right hemicolectomy using combined medial and caudal approach and divided into 2 groups group I had open surgery and group II had laparoscopic surgery

Combined Medial and Caudal Approach for Right Hemicolectomy

Safety and Feasibility of the Combined Medial and Caudal Approach in Open and Laparoscopic Radical Right Hemicolectomy for Right Colon Cancer

researchers should contact the principle investigator for individual participant data

The duration of operation was calculated in minutes in both groups. group I: open combined medial and caudal right hemicolectomy and group II: laparoscopic combined medial and caudal right hemicolectomy from skin incision till skin closure intraoperatively.

the amount of blood loss during operation is calculated in cubic centimetres using scaled container connected to suction device in both groups.

detection of organ or visceral injury was done intra operatively by naked eye in both groups.

the duration of hospital stay was detected in days in both groups

the number of resected lymph nodes was detected in post operative histopathological reports in both groups.

detection of post operative pain was detected in both groups using a written scale fulfilled by the participant giving a score from 1 out of 10 points (1 to 3 points referred as minimal) (4 to 6 points referred as mild) (7 to 10 points referred as sever).

occurrence of fecal fistula in both groups was detected by vision of fecal discharge in drains from 48 hours post operatively till discharge day.

post operative wound infection in both groups was detected by vision of wound discharge or pus.

Zagazig University

assistant lecturer of general surgery

Behaviors and Mental Disorders

Quality of Life

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.

Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.

Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)

Marco E Allaix, MD, PhD

Mario Morino, MD

Giuseppe Giraudo, MD, PhD

Alberto Arezzo, MD

Simone Arolfo, MD

Maurizio Degiuli, MD

Massimiliano Mistrangelo, MD, PhD

Roberto Passera, MD

Marco A Bonino, MD

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

While there are no differences in oncologic principles (no touch technique, proximal vessel ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen extraction may be associated with clinical benefits such as less pain and lower rates of superficial site infections; (4) laparoscopic visualization during the creation of the IIA may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to remove the specimen through any type of incision, with subsequent reduced risks of incisional hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

Some retrospective and heterogeneous studies comparing perioperative outcomes after laparoscopic right colectomy with EIA and IIA have been published in the last decade, reporting controversial results. Furthermore, the results of recent metanalyses are challenged by the heterogeneity and the poor quality of the published studies. Lastly, no comprehensive economic evaluation of the two procedures have been performed yet.

Consecutive patients with right colon tumors are included in a randomized controlled trial. This is a single Institution prospective randomized controlled trial comparing the outcomes in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm. Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA or EA according to a list of randomization numbers with treatment assignments. This list will be computer generated. An Internet application will allow central randomization.

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs include healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

A big dressing covering all incisions will be applied at the end of each operation in both arms.

Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

evaluation of the number of lymph nodes in the specimen on pathology report

percentage of patients requiring narcotics after surgery

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs included healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

the SF-12 questionnaire will assess quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme	NCT03041532	Colorectal Neop... Adenoma Detecti...	Proximal retrof... Frontal view	50 Years - 69 Years	Hospital del Río Hortega
Combined Medial and Caudal Approach for Right Hemicolectomy	NCT05128708	Colon Cancer	combined medial...	20 Years - 80 Years	Zagazig University
Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.	NCT03045107	Colon Cancer Anastomosis	Laparoscopic ri... Laparoscopic ri...	18 Years -	University of Turin, Italy
Combined Medial and Caudal Approach for Right Hemicolectomy	NCT05128708	Colon Cancer	combined medial...	20 Years - 80 Years	Zagazig University
Combined Medial and Caudal Approach for Right Hemicolectomy	NCT05128708	Colon Cancer	combined medial...	20 Years - 80 Years	Zagazig University

Spots Global Cancer Trial Database for right colon

Every month we try and update this database with for right colon cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for right colon

Every month we try and update this database with for right colon cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for right colon cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.