Wounds and Injuries

All Conditions

Neoplasms

Digestive System Diseases

Surgical Wound

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Single incision laparoscopic sigmoidectomy for sigmoid colon cancer

Single Incision Laparoscopic Sigmoidectomy

Single Incision Laparoscopic Surgery

Jae Hwan Oh, Dr. PhD.

Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.

However, there are not sufficient evidences for single incision colon surgery in colon cancer.

The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.

After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.

The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.

Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

National Cancer Center, Korea

Principal Investigator

patients with colorectal cancer and undergo single incision laparoscopic surgery

patients with colorectal cancer and undergo conventional laparoscopic surgery

Patients undergo single incision laparoscopic surgery

single incision laparoscopic surgery

Patients undergo conventional laparoscopic surgery

conventional laparoscopic surgery

Liu Kun, MD

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Single Incision Laparoscopic Colorectal Surgery

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Estimated blood loss（milliliters，ml）

Length of proximal and distal margin （centimeters，cm）

The diameter of tumors（centimeters，cm）

Duration of hospital stay（days after surgery）

Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge

Ruijin Hospital

chief physicion

Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.

Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.

Single incision laparoscopic surgery

Conventional laparoscopic surgery

Guoxin Li, M.D., PH.D.

Yanan Wang, M.D.

Guoxin Li, M.D.,PH.D.

Haijun Deng, M.D.,PH.D.

Qi Xue, M.D.

* Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
* In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
* However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.

Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,

Operative time, estimated blood loss and incision length are recorded.

Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.

Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.

Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.

Cosmetic assessment is perform using body image scale and cosmetic scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery	NCT01269060	Colorectal Canc...	Single Incision...	18 Years - 80 Years	National Cancer Center, Korea
Single Incision Laparoscopic Colorectal Surgery	NCT03151733	Laparoscopic Co...	single incision... conventional la...	18 Years - 80 Years	Ruijin Hospital
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer	NCT02117557	Colorectal Canc...	Single incision... Conventional la...	18 Years - 80 Years	Nanfang Hospital, Southern Medical University
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer	NCT02117557	Colorectal Canc...	Single incision... Conventional la...	18 Years - 80 Years	Nanfang Hospital, Southern Medical University
Single Incision Laparoscopic Colorectal Surgery	NCT03151733	Laparoscopic Co...	single incision... conventional la...	18 Years - 80 Years	Ruijin Hospital

Spots Global Cancer Trial Database for single incision laparoscopic surgery