Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?

NCT01991392 | Unknown DMC

• 1 other identifier: 201111062RIC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Nasogastric decompression was routinely used in most major intra-abdominal operations. Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting, and gastric distension). Would and respiratory complications, and to reduce the incidence of anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric decompression following elective abdominal surgery has been increasingly questioned over the last several years. Many clinical studies have suggested that this practice does not provide any benefit but could increase patient discomfort and respiratory complications. Furthermore, meta-analyses have concluded that routine nasogastric decompression is no longer warranted after elective abdominal surgery. Elective abdominal surgery without nasogastric decompression was initially tested and then widely used on patients with colorectal surgery.However, after upper gastrointestinal operations such as gastrectomy, nasogastric has been considered necessary to prevent the consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump. Therefore, studies of gastrectomy without nasogastric tube emerged later than those of colectomy. In spite more and more studies reported of no need of nasogastric tube after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive destruction and potential risk of gastric stasis after PD. However, our pilot study of retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD at our hospital showed more than 90% of patients had less than 200cc/day NG drainage amount within postoperative day three. Theoretically, these patients might not need a nasogastric tube after pancreaticoduodenectomy. Therefore, investigators propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.

Conditions

Vomiting

Keywords

Pancreaticoduodenectomy; nasogastric tube

Outcome Measures

Primary Outcomes (1)

• Complication rate

  To compare the control and modified groups, all surgical complications will be further classified by severity using a novel grading system proposed by Dindo et al. In brief, grade I and II complications include only minor deteriorations from the normal postoperative course that can be treated with drugs, blood transfusion, physiotherapy, and nutritional supply. Grade III complications require interventional treatment. Grade IV complications are life-threatening and require intensive care unit management. Death is the only grade V complication. Grade I and II complications will be classified as minor and grades III, IV, and V will be classified as major.

  two months

Study Arms (2)

Maintaining tube

ACTIVE COMPARATOR

Maintain nasogastric tube after extubation following pancreaticoduodenectomy

Device: Nasogastric tube

Non-tube

EXPERIMENTAL

Remove nasogastric tube after extubation following pancreaticoduodenectomy

Device: No nasogastric tube

Interventions

Nasogastric tube DEVICE

For nasogastric decompression.

Also known as: synphon ® (synphon comfor soft) nasogastric tube

Maintaining tube

No nasogastric tube DEVICE

For nasogastric decompression.

Also known as: synphon ® (synphon comfor soft) nasogastric tube

Non-tube

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving pancreaticoduodenectomy

You may not qualify if:

• Peritonitis history
• Present obstruction evidence or symptoms
• Previous abdominal operation
• Pregnancy
• Gastroesophageal reflux disease
• Disease causing vomitus prior to operation

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Yu-Wen Tien, Ph.D

  Natinal Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Yu-Wen Tien, Ph.D

CONTACT

ywtien5106@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

TW (1)