An interventional study of rubber water bag in Postoperative Ileus, sponsored by Erzincan Military Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Erzincan Military Hospital · Not applicable, Interventional, and Prevention
Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. [1]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization [1]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers.
Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI [1-3]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications [4-6]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan [7-15]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery.
Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain [16]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin [17]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain-producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine [18].
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 130 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Erzincan Military Hospital is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A or the control group did not pick up any therapy except our clinical standard postoperative care (ERAS protocol)
Group B served as the hot pack group boiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol).
Other: rubber water bag
bboiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol)
time to the first passage of flatus after surgery
Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant.
Time frame: up to 72 hours
The time to tolerate a solid diet
The time to tolerate a solid diet was measured from the end of operation, referred to the time when the patient awoke from anesthesia, until the patient tolerated intake of solid food (any food that required chewing) without vomiting
Time frame: Up to 5 days
The time to the first bowel movement
The time to the first bowel movement was referred to the time to the first audible bowel sound during routine postoperative care. Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant.
Time frame: up to 72 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Mar 2023, 23 months.
Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's 23 months is above that.
Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Erzincan Military Hospital