Clinical Trial: Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel

Brief Summary:

Primary Objective:

To demonstrate whether an early fixed Somatostatin treatment improves the complete recovery rate of early postoperative simple small bowel obstruction (EPSSBO) compared with the common daily practice

Notes:

  1. complete recovery= toleration of solid food+ flatus+ passage+ recovery of bowel movement.

  2. common daily practice includes:

    • NPO (Nil per mouth), re-dehydration, TPN (Total Parenteral Nutrition) if needed. Check & make sure stability of electrolytes daily.
    • GI (Gastro-Intestinal) depression via NGT (Naso-Gastric Tube)
    • Discontinue opiates, instead of NSAIDs. (Non-Steroidal Anti-Inflammatory Drugs)
    • Pro-dynamic drugs or other drugs which may interfere with GI (Gastro-Intestinal) movement eg. anti-histamines, anti-cholinergic, opiates, anti-depressives are not indicated.

Secondary Objectives:

To investigate whether an early fixed Somatostatin treatment will bring much benefit to EPSSBO pts compared with the common daily practice,for this purpose,the study will investigate the endpoints below.


Detailed Summary:

  1. Study Design:

    This is a multi-centers, open label, randomized study , and will enroll 80 EPSSBO patients, who will be assigned to two groups randomly. All the inclusive patients will be consistent with the diagnosis of EPSSBO, and the mechanic SBO or the strangulating SBO will be ruled out in advance.

    The inclusive patients will be assigned to two groups as follow(ratio 3:1)

    • Arm A: Somatostatin+common daily practice(60).
    • Arm B: common daily practice only(20).
  2. Total number of subjects:80 EPSSBO patients.

  3. Schedule of visits and assessments,The following assessments will be performed.

    • Pre-screening:informed consent,demographic data,EPSSBO diagnosis.
    • Screening
    • Daily visit:
    • Weekly visit：
    • End of study visit：

  4. Statistical methods

    • As this will be a pilot study, no formal statistical calculations were carried out and the sample size was estimated as 80 EPSSBO subjects in a 3:1 ratio of active to control subjects i.e. 60 for Stilamin+ common daily practice and 20 for common daily practice only.
    • The primary endpoint of the complete recovery rate will be estimated for both treat
      Sponsor: Nanjing PLA General Hospital

      Current Primary Outcome: Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100 [ Time Frame: 14 days ]

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Average recovery time [ Time Frame: 14 days ]
      • Re-surgery rate [ Time Frame: 14 days ]
      • Average NG (naso-gastric) aspirate volume [ Time Frame: 14 days ]
      • Average re-dehydration volume [ Time Frame: 14 days ]
      • Change of blood electrolytes [ Time Frame: 14 days ]
      • Degree of symptom and sign relief [ Time Frame: 14 days ]


      Original Secondary Outcome: Same as current

      Information By: Nanjing PLA General Hospital

      Dates:
      Date Received: March 5, 2010
      Date Started: June 2009
      Date Completion:
      Last Updated: August 2, 2011
      Last Verified: February 2010