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DeutschThe NoTamp study is being conducted to gain insights into the safety, suitability and performance of the use of a tamponade dressing after hemorrhoidectomy.
Participation in this clinical trial is voluntary.
Patients are included in study sites throughout Germany (see overview in the login area).
The study was approved by an ethics committee. A total of 953 patients are expected to participate in this study in Germany.
The trial has been initiated by the study leader Prof. Dr. Langenbach and is funded by the Helios Research Fund.
The Division of Clinical Research of the Institute for Research in Operative Medicine (IFOM) of the Private University of Witten / Herdecke, located in Building 38 at Ostmerheimer Straße 200 in 51109 Cologne, supports the preparation of the study, supervises the implementation of the trial and is responsible for the data analysis, the reporting and is involved in the publication of the results.
In the past tamponade dressings after hemorrhoidectomy, what means the surgical removal of diseased hemorrhoids, were used as a standard for hemostasis.
This approach is increasingly being abandoned.
In this study we would like to compare this approach with a care without the use of tampons.
Through this clinical trial, we hope to gain further insights into the safety and performance of these care alternatives. Within this clinical study, both for the standard therapy and the care alternative the severity of the pain after the operation and how often there is bleeding within 7 days after the surgery which requires surgical follow-up treatment should be determined.
The results of the treatment groups are compared to determine whether the omission of tamponades after hemorrhoidectomy is not inferior to the use of tampons with respect to postoperative bleeding, while at the same time there is lower pain. Patients participating in this study are either treated without a tamponade in the so-called intervention arm or with a tamponade in the standard arm. The decision for the treatment that will be applied will be made by a previously determined random procedure, comparable to throwing a coin (randomization). The tamponade in the patients treated with the standard therapy will be automatically removed with the first defecation, at the latest after 24 hours. If the tamponade is removed by any circumstance before, it will not be replaced except for severe bleeding.
The duration of the clinical trial is 7 days for each patient. After surgery, the participants are interviewed about their pain and quality of life at different times (6, 12, 24 and 48 hours) using a specific questionnaire. On the day of discharge from the hospital, which usually takes place between the 2nd and 4th day after surgery, participants will be asked again about their state of health and to complete the questionnaire on the quality of life. On the seventh day after the surgical procedure, a follow-up examination will be carried out, for which the participants must return to the clinic. Here the healing progress of your wound is reviewed again and a new survey is carried out according to your health condition and your pain intensity. At this time, patients are asked to fill in the questionnaire on the quality of life again and to answer some questions about their satisfaction with the treatment. Participation in this clinical trial does not incur any costs for the participants. The participants do not receive any compensation.
Through this clinical trial, we hope to gain further insights into the safety and performance of these care alternatives. Within this clinical study, both for the standard therapy and the care alternative the severity of the pain after the operation and how often there is bleeding within 7 days after the surgery which requires surgical follow-up treatment should be determined.
The results of the treatment groups are compared to determine whether the omission of tamponades after hemorrhoidectomy is not inferior to the use of tampons with respect to postoperative bleeding, while at the same time there is lower pain. Patients participating in this study are either treated without a tamponade in the so-called intervention arm or with a tamponade in the standard arm. The decision for the treatment that will be applied will be made by a previously determined random procedure, comparable to throwing a coin (randomization). The tamponade in the patients treated with the standard therapy will be automatically removed with the first defecation, at the latest after 24 hours. If the tamponade is removed by any circumstance before, it will not be replaced except for severe bleeding.
The duration of the clinical trial is 7 days for each patient. After surgery, the participants are interviewed about their pain and quality of life at different times (6, 12, 24 and 48 hours) using a specific questionnaire. On the day of discharge from the hospital, which usually takes place between the 2nd and 4th day after surgery, participants will be asked again about their state of health and to complete the questionnaire on the quality of life. On the seventh day after the surgical procedure, a follow-up examination will be carried out, for which the participants must return to the clinic. Here the healing progress of your wound is reviewed again and a new survey is carried out according to your health condition and your pain intensity. At this time, patients are asked to fill in the questionnaire on the quality of life again and to answer some questions about their satisfaction with the treatment. Participation in this clinical trial does not incur any costs for the participants. The participants do not receive any compensation.
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